The LASIK industry & the FDA have conspired since LASIK's inception to purposely withhold information vital to the public in making a truly informed LASIK decision. With Lasikdecision.com, The hope is to show you what the industry and FDA would not and did not even think of doing until LASIK casualties started speaking out, and yet, they still did NOTHING.
Studies & Articles
TOP TEN REASONS NOT TO HAVE LASIK EYE SURGERY PDF Print E-mail

Opinions By Damaged LASIK Patients For Those Considering LASIK

1. LASIK causes dry eye

Dry eye is the most common complication of LASIK. Corneal nerves that are responsible for tear production are severed when the flap is cut. Medical studies have shown that these severed nerves never return to normal densities. Symptoms of dry eye include pain, burning, foreign body sensation, and eyelid sticking to the eyeball. The FDA website warns that LASIK-induced dry eye may be permanent.

2. LASIK results in loss of visual quality

LASIK patients have more difficulty seeing detail in dim light (known as loss of contrast sensitivity), and also experience an increase in visual distortion at night (multiple images, halos, and starbursts). The FDA website warns that patients with large pupils may suffer from debilitating visual symptoms at night.

3. The cornea is incapable of complete wound healing after LASIK

Researchers found that the flap heals to only 2.4% of normal tensile strength. LASIK flaps can be surgically lifted or accidentally dislodged for the remainder of a patient’s life. For these reasons, the FDA website warns that patients who participate in contact sports are not good candidates for LASIK.

Collagen bands of the cornea provide its form and strength. LASIK severs these collagen bands and thins the cornea, resulting in permanent weakening. The thinner, weaker post-LASIK cornea is more susceptible to forward bulging due to normal intraocular pressure, which may progress to a condition known as keratectasia and corneal failure, requiring corneal transplant.

4. The true rate of LASIK complications is unknown

There is no clearinghouse for reporting of LASIK complications. Side effects occur frequently but are downplayed by LASIK surgeons. Moreover, there is no consensus among LASIK surgeons on the definition of a complication.

5. LASIK results in loss of near vision

Nearsighted patients who do not have LASIK retain the ability to see up close naturally after the age of 40 simply by removing their glasses. LASIK patients over the age of 40 may discover they have traded one pair of glasses for another.

6. There are long-term negative consequences of LASIK

LASIK affects the accuracy of intraocular pressure measurements, exposing patients to risk of blindness from undiagnosed glaucoma.

Like the general population, LASIK patients will develop cataracts later in life. Calculation of intraocular lens power for cataract surgery is inaccurate after LASIK. This may result in poor vision following cataract surgery and exposes patients to increased risk of repeat surgeries. Ironically, steroid drops routinely prescribed after LASIK hasten the onset of cataracts.

7. Bilateral simultaneous LASIK is not in patients’ best interest

In a 2003 survey of American Society of Cataract and Refractive Surgery (ASCRS) members, 91% of surgeons who responded did not offer patients the choice of having one eye done at a time. Performing LASIK on both eyes in the same day places patients at risk of vision loss in both eyes, and denies patients informed consent for the second eye.

8. Serious complications may emerge later

The medical literature is filled with reports of late onset LASIK complications such as loss of the cornea due to biomechanical instability, vision-threatening infection, inflammation resulting in corneal haze, flap dislocation, and retinal detachment. Complications may emerge weeks, months, or years after “successful” LASIK.

9. Rehabilitation options after LASIK are limited

LASIK is irreversible, and treatment options for complications are extremely limited. Hard contact lenses may provide visual improvement if the patient can obtain a good fit and tolerate lenses. The post-LASIK contact lens fitting process can be time consuming, costly and ultimately unsuccessful. Many patients eventually give up on hard contacts and struggle to function with impaired vision. In extreme cases, a corneal transplant is the last resort and does not always result in improved vision.

10. Safer alternatives to LASIK exist

Some leading surgeons have already abandoned LASIK for surface treatments, such as PRK, which do not involve cutting a corneal flap. It is important to remember that LASIK is elective surgery. There is no sound medical reason to risk vision loss from unnecessary surgery. Glasses and contact lenses are the safest alternatives.

 
Flap Studies & Articles PDF Print E-mail

These quick-links will provide you faster access to the studies & articles provided: 

Accidental self-removal of a flap - a rare complication of LASIK surgery - - To report a rare complication in which the patient accidentally removed the LASIK corneal flap.

LASIK Flap Only 2.4% as strong as Normal Cornea - The human corneal stroma typically heals after LASIK in a limited and incomplete fashion; this results in a weak, central and paracentral hypocellular primitive stromal scar that averages 2.4% as strong as normal corneal stroma.

Traumatic corneal flap dislocation one to six years after LASIK in nine eyes with a favorable outcome - To report our experience treating eye trauma after LASIK refractive surgery.

Comparison of residual stromal bed and flap thickness in primary and repeat LASIK in myopic patients - To compare the change in residual stromal thickness and flap thickness between primary laser in situ keratomileusis (LASIK) and repeat LASIK in myopic patients.

Central Flap Necrosis After LASIK With Microkeratome and Femtosecond Laser Created Flaps - To report nine cases of severe central flap inflammation and necrosis after LASIK.

Flap Displacement during Vitrectomy 24 months after LASIK - “The LASIK flap never heals… the LASIK flap can be easily dislodged from simple contact with the eye such as a finger poke.”

Traumatic flap displacement and DLK after LASIK - Traumatic flap displacement and subsequent diffuse lamellar keratitis after laser in situ keratomileusis.

Late-onset flap folds and partial dehiscence of flap - Late-onset repetitive traumatic flap folds and partial dehiscence of flap edge after laser in situ keratomileusis.

Late traumatic dislocation of LASIK flaps  (1) - A case of traumatic flap displacement with a fingernail injury four years after LASIK is reported.

Late traumatic dislocation of LASIK flaps  (2) - The second patient had a blunt trauma that caused a dislocation of the flap.

Flap tearing during lift-flap LASIK retreatment - This report suggests that flaps with margins near the limbus or a corneal pannus may be prone to an earlier and stronger healing process at the edge that may lead to a flap tear during LASIK retreatment.

Precision of flap measurements for LASIK in 4428 eyes - Flap thickness varies significantly depending on the microkeratome used. Factors that influence flap thickness are primarily corneal thickness, patient age, preoperative keratometry, preoperative refraction including astigmatism, and corneal diameter.

Predictability of corneal flap thickness in LASIK using three different microkeratomes - Corneal flap thickness tended to be considerably thinner than expected on both eyes using the ACS and Hansatome.

Inaccurate Flap Cut - Here is a case report of a woman who developed ectasia following LASIK due to in accurate flap cut.

Late traumatic displacement of LASIK flaps - Laser in situ keratomileusis corneal flaps are vulnerable to traumatic dehiscence and dislocation, which can occur more than 2 years after the procedure.

Traumatic flap dislocation 4 years after LASIK - The patient was examined 5 days after being struck in the face and found to have a flap dislocation.

Mismatch between flap and stromal areas after LASIK as source of flap striae - Excess flap area may cause striae because of wrinkling.

Uveitis-associated flap edema and lamellar interface fluid collection after LASIK - To report two cases of corneal pathology associated with anterior uveitis after LASIK.

Noninflammatory flap edema after lasik associated with asymmetrical preoperative corneal pachymetry - To report persistent unilateral flap edema following LASIK in patients with asymmetrical central corneal thickness.

Evaluation of corneal flap dimensions and cut quality using the SKBM automated microkeratome - To evaluate flap dimensions and cut quality with repeated blade use of the automated Summit Krumeich-Barraquer microkeratome (SKBM [LadarVision])

Flap-related complications present challenges for surgeons

Surgeons review some common flap-related problems and how to handle them.

By Amar Agarwal, MS, FRCS, FRCOphth; Jairo Hoyos, MD; Melania Cigales, M

Flap-related problems after LASIK are a concern for any refractive surgeon. Common causative factors are inadequate suction, microkeratome malfunction and corneal curvature anomalies. This article reviews some common complications and ways to avoid or manage them.

Read the FULL ARTICLE

Microstriae

 

Quote:  Microstriae are very faint, small, disorganized, superficial wrinkles in the LASIK flap. Unlike macrostriae, which result from the flap’s slippage, microstriae are produced by the mechanical forces of a LASIK flap...

Traumatic late flap dehiscence and Enterobacter keratitis following LASIK - To report a case of traumatic flap dehiscence and Enterobacter keratitis 34 months after LASIK.

Flap interface particles are another finding whose clinical significance is undetermined.

A Finnish study found that particles of various sizes and reflectivity were clinically visible in 38.7% of eyes examined via slit lamp biomicroscopy, but apparent in 100% of eyes using confocal microscopy.

Some patients have reported large chunks of metal in their corneas after lasik.

Watch a video of a confocal exam of another LASIK patient with an extraordinary amount of metallic debris from the LASIK microkeratome blade.

LASIK Blade Leaves Metal Under Flap

LASIK flap disintegrates during lifting

Read more...
 
Dry Eye Studies & Articles PDF Print E-mail

Dry Eye After LASIK - The risk of chronic dry eye after LASIK was significantly higher in Asian eyes. Contributing factors could include racial differences in eyelid and orbital anatomy, tear film parameters and blinking dynamics and higher attempted refractive corrections in Asian eyes.

Chronic dry eye and regression after LASIK for myopia - The risk for refractive regression after LASIK was increased in patients with chronic dry eye.

The incidence and risk factors for developing dry eye after myopic LASIK - To determine the incidence and risk factors after myopic LASIK.

Autologous Serum Eye Drops for dry eye after LASIK - To evaluate the efficacy of these drops for dry eye after LASIK in a prospective, randomized study. 

Symptoms of dry eye and recurrent erosion syndrome after refractive surgery - These symptoms occurred commonly after excimer laser procedures but were significantly more common, more severe, and more prolonged after PRK.

Dealing With Dry Eye - An article written for FDA Consumer magazine.

Dry Eye and Corneal Sensitivity After High Myopic LASIK - To assess subjective symptoms and objective clinical signs of dry eye and investigate corneal sensitivity after high myopic LASIK.

 
Pupil Related Studies & Articles PDF Print E-mail

Pupil measurement using the Colvard pupillometer and a standard pupil card with a cobalt blue filter penlight - To compare scotopic pupil measurements obtained with a Colvard pupillometer with measurements taken with a printed pupil gauge and penlight with a cobalt blue filter attachment in mesopic and scotopic luminance.

Influence of pupil and optical zone diameter on higher-order aberrations after wavefront-guided myopic LASIK - To investigate the influence of pupil and optical zone (OZ) diameter on higher-order aberrations (HOAs) after myopic wavefront-guided laser in situ keratomileusis (LASIK)

Pupillary Dilation

1) Pupillary dilation from 3 to 7 mm in post-refractive surgery patients found to cause 28- to 46-fold increase in aberrations! - Both photorefractive keratectomy and laser in situ keratomileusis increase the wavefront aberrations of the cornea and change the relative contribution of coma- and spherical-like aberrations.

2) Pupillary dilation from 3 to 7 mm in post - PRK patients found to cause 25-to 32-fold increase increase in aberrations! - After surgery, the same dilation resulted in a 25- to 32-fold increase in the photorefractive keratectomy group and a 28- to 46-fold increase in the laser in situ keratomileusis group.

Pupil Size

Pupil size and night vision disturbances after LASIK for myopia. - Large pupil size measured preoperatively is correlated with an increased frequency of subjectively experienced post-LASIK visual disturbances during scotopic conditions.

Large pupils lead to night vision problems, physicians suggest

SOURCE

 

EyeWorld

November, 2005

Excerpt:

While some studies have suggested pupil size has little to no effect on nighttime vision post-refractive surgery, some ophthalmologists point to new evidence that there is a correlation.

“If you compare patients of the same prescriptions, the larger the pupil size, the bigger the chance that they’re going to have more night vision problems,” said William B. Trattler, M.D., Center for Excellence in Eye Care, Miami.

To back up his assertion, Dr. Trattler performed his own studies, one of which included 119 myopic eyes that underwent LASEK or PRK with either a standard VISX (Advanced Medical Optics, Santa Ana, Calif.) Star S3 or S4 laser.

Using a Larson Glarometer, he found that the radius of starbursts was greater in patients with large pupils compared with those in patients with small ones. Dr. Trattler presentedthe results at the most recent ASCRS•ASOA Symposium & Congress. The Larson Glarometer does not have a corporate manufacturer yet. It was developed and is distributed by Bruce Larson, M.D., Hinsdale, Ill.

Meanwhile, James Salz, M.D., clinical professor of ophthalmology, University of Southern California, Los Angeles, also believes large pupils can lead to night vision complaints after refractive surgery.

“The larger the pupil size, the greater the aberrations will be,” said Dr. Salz.

Pupil diameter changes and reaction after posterior chamber phakic intraocular lens implantation - To compare the different aspects of pupil constriction before and after the implantation of an implantable contact lens (ICL).

Effect of pupil size on visual function under monocular and binocular conditions in LASIK and non-LASIK patients - To compare binocular and monocular vision in patients treated with laser in situ keratomileusis (LASIK) and in non-LASIK patients.

Read more...
 
Corneal Studies & Articles PDF Print E-mail

Wound healing in the cornea: a review of refractive surgery complications and new prospects for therapy - The corneal wound healing response is of particular relevance for refractive surgical procedures since it is a major determinant of efficacy and safety. The purpose of this review is to provide an overview of the healing response in refractive surgery procedures.

Long-term corneal keratoctye deficits after photorefractive keratectomy and LASIK - To measure changes in keratocyte density up to 5 years after photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK).

Estimation of true corneal power after keratorefractive surgery in eyes requiring cataract surgery: BESSt formula - To describe a new formula, BESSt, to estimate true corneal power after keratorefractive surgery in eyes requiring cataract surgery.

Considerations of glaucoma in patients undergoing corneal refractive surgery - Corneal thickness, which is modified during corneal refractive surgery, plays an important role in monitoring glaucoma patients because of its effect on the measured intraocular pressure.

Corneal Keratocyte Deficits After PRK and LASIK - To measure changes in keratocyte density up to 5 years after PRK and LASIK.

Effective corneal refractive diameter as a function of the object tangent angle in visual space - To determine whether the currently accepted method of selecting a minimum optical zone diameter for laser refractive surgery that is equal to or slightly greater than the dark-adapted pupil diameter provides a sufficient diameter of corneal surface to focus light arising from objects in the paracentral and peripheral visual field.

Evaluation of Corneal Sensitivity to Mechanical and Chemical Stimuli After LASIK: A Pilot Study - To evaluate the effect of laser in situ keratomileusis (LASIK) on corneal sensitivity, nerve morphology, and tear film characteristics.

Changes in corneal thickness and curvature after different excimer laser photorefractive procedures and their impact on intraocular pressure measurements - To analyze the changes in central corneal thickness (CCT) and curvature before and after different excimer laser photorefractive procedures and their possible impact on intraocular pressure (IOP) estimations with Goldmann applanation tonometry.

Effect of Corneal Curvature and Corneal Thickness on the Assessment of Intraocular Pressure Using Noncontact Tonometry in Patients After Myopic LASIK Surgery - To evaluate the effect of corneal curvature and corneal thickness on the assessment of intraocular pressure (IOP) using noncontact tonometry (NCT) in patients after myopic LASIK surgery.

Failed LASIK Depleting Supply Of Donor Corneas - Optometrist specializing in post-refractive surgery disaster claims that FAILED LASIK EYE SURGERY IS DEPLETING SUPPLY OF DONOR CORNEAS.

Epidemic of Corneal Weakening After Refractive Surgery - Here is an excerpt and link to a comment posted by Optometrist Dr. Greg Gemoules who specializes in the treatment of patients damaged by refractive surgery by fitting them with rigid gas permeable contact lenses.

Effect of Corneal Curvature and Corneal Thickness on the Assessment of Intraocular Pressure Using Noncontact Tonometry in Patients After Myopic LASIK Surgery -  Even if a residual corneal bed of 300 microm or thicker is preserved, anterior bulging of the cornea after LASIK can occur.

Structural Analysis of the Cornea Using Scanning-Slit Corneal Topography in Eyes Undergoing Excimer Laser Refractive Surgery - Myopic PRK and LASIK induce significant forward shifts of the cornea, which are not true corneal ectasia.

Permanent Disease Changes Present in all Post-LASIK Corneas! - Permanent pathologic changes were present in all post-LASIK corneas. These changes were most prevalent in the lamellar interface wound. These changes along with other pathologic alterations in post-LASIK corneas may change the functionality of the cornea after LASIK.

Corneal Nerve Damage Continues to Increase years 2-3 after LASIK - Both subbasal and stromal corneal nerves in LASIK flaps recover slowly and do not return to preoperative densities by 3 years after LASIK.

Critical thoughts on current laser surgery of the cornea (1995) - If we look at refractive surgery, especially laser photoablation, in the context of the needs for ophthalmic care of the whole world, then this type of surgery is out of proportion.

Theoretical Elastic Response of the Cornea to Refractive Surgery: Risk Factors for Keratectasia - "In particular, a forward shift and an increase in power of the posterior surface was predicted for myopic LASIK, in agreement with previous experimental findings." 

Cohesive tensile strength of human LASIK wounds with histologic, ultrastructural, and clinical correlations - The human corneal stroma typically heals after LASIK in a limited and incomplete fashion; this results in a weak, central and paracentral hypocellular primitive stromal scar that averages 2.4% as strong as normal coeneal stroma.

Pathologic findings in postmortem corneas after successful LASIK - Permanent pathologic changes were present in all post-LASIK corneas. These changes were most prevalent in the lamellar interface wound. These changes along with other pathologic alterations in post-LASIK corneas may change the functionality of the cornea after LASIK.

Ex vivo confocal microscopy of human LASIK corneas with histologic and ultrastructural correlation - Confocal microscopy, along with histologic and ultrastructural correlations, demonstrated that the most prevalent alterations in the centers of LASIK corneas were a slightly thickened epithelium caused by focal basal epithelial cell hypertrophic modifications, random undulations in Bowman's layer over the flap surface, and a variably thick hypocellular primitive stromal interface scar.

Corneal reinnervation after LASIK: prospective 3-year longitudinal study - Both subbasal and stromal corneal nerves in LASIK flaps recover slowly and do not return to preoperative densities by 3 years after LASIK.

Progression to end-stage glaucoma after LASIK - 2 patients, one a glaucoma suspect because of family history and the other with juvenile glaucoma.

Steroid-induced glaucoma after LASIK associated with interface fluid - To report the ocular manifestations and clinical course of eyes developing interface fluid after LASIK.

Biomechanical modeling of refractive corneal surgery - A biomechanical study before surgery is therefore very convenient to assess quantitatively the effect of each parameter on the optical outcome.

Confocal Microscopy of Corneal Flap Microfolds After LASIK - To describe the morphological characteristics of microfolds that appear at the corneal flap after LASIK, as seen under confocal microscopy.

Objective method to measure corneal clarity before and after LASIK - To develop, evaluate, and use an objective method to determine the effect of LASIK on corneal clarity.

Histopathology of corneal melting associated with diclofenac use after refractive surgery - To describe the histopathology of the cornea in 3 cases of corneal melting associated with diclofenac therapy after refractive surgery procedures.

Central corneal iron deposition after myopic LASIK - To describe central corneal iron deposition after myopic LASIK.

Corneal ectasia after LASIK in patients without apparent preoperative risk factors - To evaluate patients who developed ectasia with no apparent preoperative risk factors.

Interface Corneal Edema Secondary to Steroid-induced Elevation of Intraocular Pressure Simulating DLK - To describe interface corneal edema secondary to steroid-induced elevation of intraocular pressure (IOP) following LASIK.

Delayed Ectasia Following LASIK With No Risk Factors: Is a 300-µm Stromal Bed Enough? - To report a case of ectasia occurring >4 years following LASIK with no risk factors and a residual stromal bed >300 µm.

Steroid glaucoma after laser in situ keratomileusis - A steroid-induced glaucoma may develop after bilateral laser in situ keratomileusis (LASIK)  with normal intraocular pressure in applanation tonometry.

Keratocytes' Density Remains Low After Refractive Surgery  - According to a paper presented this month at the 6th International Congress on Advanced Surface Ablation and SBK, keratocytes' density decreases substantially in the anterior stroma of  refractive surgery patients during the first postoperative year and remains low for several years.

Risk Assessment for Ectasia after Corneal Refractive Surgery - To analyze the epidemiologic features of ectasia after excimer laser corneal refractive surgery, to identify risk factors for its development, and to devise a screening strategy to minimize its occurrence.

More on the cornea...

Read more...
 
Spherical Aberrations PDF Print E-mail

Spherical Aberration and Its Symptoms - Theories on why it occurs and how new technology may address the problem.

Spherical Aberrations - Spherical aberration is one of the most important problems that can occur after laser eye surgery, in particular with high myopic corrections.

 

 

 
Femtosecond Lasers & LASIK Studies & Articles PDF Print E-mail

IntraLase: Changing the LASIK Landscape - Though the exact cause of TLS is still uncertain, some surgeons believe that the inflammation is caused by necrotic cellular debris…

Transient light sensitivity a minor complication of IntraLase use - Some users of the IntraLase femtosecond laser keratome first noticed the complication when they began working with the system more than 2 years ago. Since then, the phenomenon has gone under multiple names.

Transient light-sensitivity syndrome after LASIK with the femtosecond laser Incidence and prevention - To describe the incidence of transient light-sensitivity syndrome (TLSS) after laser in situ keratomileusis (LASIK) with the femtosecond laser and to identify preventive strategies.

Flap folds after femtosecond LASIK - To report a case of bilateral flap folds after a laser-assisted in situ keratomileusis (LASIK) procedure in which the flap was created by the femtosecond laser.

Macular hemorrhage after laser in situ keratomileusis (LASIK) with femtosecond laser flap creation - To report the first case of macular hemorrhage following LASIK with femtosecond laser flap creation.

Refractive surgery: lessons to be learned - "Indeed the long-term problems created by laser refractive surgery are not yet a major issue, but soon will be."

Complications of refractive excimer laser surgery - A German article related to complications.

A comparative confocal microscopy analysis after LASIK with the IntraLase femtosecond laser vs Hansatome microkeratome - To evaluate and compare confocal microscopy findings between a femtosecond laser and a mechanical microkeratome.

Comparison of goblet cell density after femtosecond laser and mechanical microkeratome in LASIK - To study the effect of the LASIK procedure performed with a femtosecond laser and a manual microkeratome on the conjunctival goblet cell and epithelial cell populations.
Read more...
 
Wavefront Related Studies & Articles PDF Print E-mail

Wavefront analysis in post-LASIK eyes - In post-LASIK eyes, wavefront refraction components were poorly correlated to manifest and cycloplegic components.

Complex wavefront-guided retreatments with the Alcon CustomCornea platform after prior LASIK - To report the results of complex wavefront-guided LASIK retreatments.

Wavefront-guided LASIK and fractional clearance - The optical zone/pupil ratio (fractional clearance, FC) has a significant impact on HOA induction after wavefront guided LASIK.

Predicting Patients' Night Vision Complaints With Wavefront Technology - To evaluate the accuracy of the diagnostic capabilities of optical metrics generated from wavefront measurements in relationship to post–laser assisted in situ keratomileusis (LASIK) visual complaints as expressed and drawn by patients.

Maximum permissible lateral decentration in aberration-sensing and wavefront-guided corneal ablation - To investigate the lateral alignment accuracy needed in wavefront-guided refractive surgery to improve the ocular optics to a desired level in a percentage of normally aberrated eyes.

Surgeons Opinions on Wavefront: The Demise of Conventional LASIK? - Will customized LASIK procedures replace standard treatments?

Measurement of Contrast Sensitivity and Glare Under Mesopic and Photopic Conditions Following Wavefront-guided and Conventional LASIK Surgery - To compare contrast and glare vision in a prospective study of eyes treated using conventional and wavefront-guided LASIK surgery. The reproducibility of a glaremeter device used to quantitatively measure glare and halo was also determined.

Spot size and quality of scanning laser correction of higher-order wavefront aberrations - To investigate the effect of laser spot size on the outcome of aberration correction with scanning laser corneal ablation.

 
Retinal Studies & Articles PDF Print E-mail

Full-thickness macular hole after LASIK for the correction of myopia - To describe 19 patients (20 eyes) who developed a macular hole (MH) after undergoing bilateral LASIK for the correction of myopia.

Lattice Degeneration With And Without Atrophic Holes - Illustrates an important point that lattice degeneration is quite common, occuring in 8-11 percent of the population.

Retinal phlebitis after LASIK - To report a case of retinal phlebitis with cystoid macular edema in both eyes 8 weeks after LASIK.

Two cases of retinal detachment - Following laser in Situ keratomileusis repaired by scleral buckling surgery.

Bilateral retinal detachment after laser in situ keratomileusis - Another case of retinal detachment after LASIK.

Early rhegmatogenous retinal detachment following LASIK for high myopia - Four eyes had early rhegmatogenous retinal detachment within 3 months of LASIK for correction of high myopia using the microkeratome, Clear Corneal Molder.

Retinal detachment after Excimer laser (myopic LASIK or PRK) - A retrospective multicentric study: 15 cases.

Proposed mechanism for retinal tears after LASIK: an experimental model - To demonstrate axial length changes associated with anterior shift of the lens/iris diaphragm and anterior vitreous base in human cadaver eyes during suction ring application preceding Moria LASIK, and to propose that these changes may be associated with anterior retinal tears.

Vitreoretinal alterations following laser in situ keratomileusis: clinical and experimental studies - The presence of vitreoretinal changes following laser in situ keratomileusis in myopia is evaluated.

Diffuse lamellar keratitis - Several studies related to Diffuse lamellar keratitis, with (submitted) commentary.

Late Onset Lamellar Keratitis and Epithelial Ingrowth Following Orbital Cellulitis - To report a case of late onset lamellar keratitis and epithelial ingrowth associated with orbital cellulitis 1 month after LASIK surgery.

A predictive model for postoperative intraocular pressure among patients undergoing LASIK - To develop a predictive model based on preoperative variables for estimating postoperative intraocular pressure (IOP) of those eyes undergoing LASIK.

Retinal nerve fiber layer thickness changes after an acute increase in intraocular pressure - To determine whether the increase in intraocular pressure (IOP) for 45 seconds during laser in situ keratomileusis (LASIK) suction can induce a decrease in retinal nerve fiber layer thickness (RNFLT) assessed by a confocal scanning laser polarimeter.

Retinal Nerve Fiber Layer Thickness Change after Photorefractive Surgery - To analyze the retinal nerve fiber layer (RNFL) change after photorefractive surgery.

Read more...
 
Contacts, Implants, etc. Related Articles & Studies PDF Print E-mail

Contact Wearers, Beware! - "Many patients in the United States go blind every day from the use of contact lenses (especially when patients sleep in them)." - Dr. William Trattler: July 1999 asklasikdocs forum posting.

Contact lens overrefraction variability in corneal power estimation after refractive surgery - To evaluate the accuracy and precision of the contact lens overrefraction (CLO) method in determining corneal refractive power in post-refractive-surgery eyes.

Contact lens fitting post-refractive surgery - A number of patients who had undergone refractive surgery still required contact lens fitting.

Intrastromal corneal ring implantation for the correction of myopia: 12-month follow-up - To evaluate the efficacy, predictability, and stability of refraction obtained after intrastromal corneal ring segment (ICRS) implantation for low to moderate myopia.

 

 
IOL/IOP Related Studies & Articles PDF Print E-mail
A Correction Formula for the Real Intraocular Pressure After LASIK for the Correction of Myopic Astigmatism - To create a correction formula to determine the real intraocular pressure (IOP) after LASIK considering the altered corneal thickness, corneal curvature, and corneal stability.

Measurement of intraocular pressure after LASIK by dynamic contour tonometry - Changes of corneal properties induced by laser in situ keratomileusis (LASIK) results in low inaccurate intraocular pressure (IOP) readings by Goldmann applanation tonometry (GAT).

Early Transient Visual Acuity Loss After LASIK Due to Steroid-induced Elevation of Intraocular Pressure - To report the clinical course of early transient reduction of uncorrected visual acuity (UCVA) after LASIK surgery resulting from steroid-induced elevation of intraocular pressure (IOP).

Change in IOP measurements after LASIK the effect of the refractive correction and the lamellar flap - To study the relationship between intraocular pressure (IOP) readings after LASIK and the amount of refractive correction.

The AS biometry technique-A novel technique to aid accurate intraocular lens power calculation after corneal laser refractive surgery - IOL calculation for cataract surgery has been shown to be inaccurate after PRK, LASEK, and LASIK. This technique is to determine difference to clinical history method (CHM).

Effect of microkeratome suction during LASIK on ocular structures - To study the effect of microkeratome suction on ocular structures during LASIK.

A predictive model for postoperative intraocular pressure among patients undergoing LASIK - To develop a predictive model based on preoperative variables for estimating postoperative intraocular pressure (IOP) of those eyes undergoing LASIK surgery, to predict the amount of underestimated IOP after LASIK for myopia and myopic astigmatism.

Preventing IOP increase after phacoemulsification and the role of perioperative apraclonidine - To evaluate the effectiveness of prophylactic topical apraclonidine 1% in preventing an intraocular pressure (IOP) rise in the early period after uneventful phacoemulsification with intraocular lens (IOL) implantation.

Accurate intraocular lens power calculation after myopic LASIK, bypassing corneal power - To describe a novel method for calculating intraocular lens (IOL) power after myopic laser in situ keratomileusis (LASIK) without using the inaccuracies of the post-LASIK corneal power.

Angle-supported phakic IOLs withdrawn from the French market  - Angle-supported phakic IOLs will no longer be sold and implanted in France due to an alarming amount of endothelial cell loss found in a significant number of patients 2 to 3 years after implantation.

Ocular Structure Changes During Vacuum by the Hansatome Microkeratome Suction Ring - To evaluate whether the vacuum of a microkeratome suction ring induces ocular structure changes. 

Patients are not informed that IOP measurements after LASIK are not accurate. This can have serious implications for patients. High IOP must be treated in order to avoid permanent vision loss.

Read more...
 
Other Eye Related Studies & Articles PDF Print E-mail

The Threshold Concept - The point is that refractive surgery has robbed millions of their visual and corneal nerve reserves. Millions of Americans have been pushed nearer the threshold for dry eye, loss of functional night vision, and corneal failure (ectasia).

The Eyes Are The Windows To The Soul - The eyes are the windows to the soul. And the relatively new LASIK procedure supposedly can make those windows crystal clear. An article by Meredith Perry

An Eye For An Eye: Professor O'Reilly Speaks Out - Laser eye surgery is remarkable. Never before in American medical history have 3 million people each year responded to massive advertising by paying for an innovative, elective surgery. Never before have surgeons competed so vigorously on price; and never has a surgery been so skillfully isolated from liability lawsuits. If LASIK eye surgery becomes the Mass Tort of 2025, will Americans regret accepting it as the benign 20/20 solution of today?

Cancer & Laser Eye Surgery - At a time when there has been a significant improvement in the technology of treatment of refractive errors by laser in-situ keratomileusis (LASIK), this author has issued a very timely warning both to patients undergoing the procedure and to the people performing LASIK.

10 million not enough, stronger sales skills needed - Why refractive surgeons must adopt a philosophy of continuous improvement.

What's OK by the FDA... - A surgeon can give patients 2 diopters of induced astigmatism as long as it's less than 5% of eyes. That's a LOT of blurry vision folks, and for the record... induced astigmatism was not in my informed consent materials. Was it in yours?

Surface ablation yielded better biomechanical stability vs. LASIK in study - Regardless of how thick or thin LASIK flaps are made, the flaps cause a considerable reduction in corneal biomechanical stability compared with surface ablation procedures, according to a study presented here.

Visual Field Defect after LASIK - To report a case of visual field defect associated with laser in situ keratomileusis.

Infraorbital nerve palsy: A complication of laser in situ keratomileusis - To report infraorbital nerve dysfunction after laser in situ keratomileusis.

A Cluster of Nocardia Keratitis After LASIK - To report a cluster of Nocardia asteroides keratitis cases after LASIK.

Bilateral Bacterial Keratitis in Three Patients Following Photorefractive Keratectomy - To report clinical manifestations and the bacteriologic profiles of three patients with bilateral bacterial keratitis following photorefractive keratectomy (PRK).

Potential new post-laser refractive surgery complication identified - A new syndrome characterized by noninflammatory corneal opacification  can occur in some patients within 9 days after undergoing LASIK or PRK, according to a study.

Functional optical zone after myopic LASIK as a function of ablation diameter - Glare is induced by rays of light that enter the pupil through the portion of the cornea outside the ablation area.

Vision standards for driving in Canada and the United States - A review for the Canadian Ophthalmological Society.

Dangers of Suction Ring and Laser Acoustic Shock - This barotrauma is analagous to what happens in closed eye injury, and can alter delicate retinal structures, especially small vessels, and induce vitreoretinal traction at the vitreous base and posterior pole.

Effect of microkeratome suction during LASIK on ocular structures - During application of microkeratome suction, the lens thickness decreases, whereas the vitreous distance increases, suggesting anterior traction on the posterior segment.

Survey Finds 1 In 3 Americans Dissatisfied With LASIK - 1 in 3 respondents who encountered post-Lasik problems still wear their glasses or contacts and 1 in 7 of all respondents underwent a second Lasik operation.

13% of post-LASIK eyes have posterior vitreous detachment! - Considering the data from the 100 eyes, this corresponds to 13%;

Plastic particles at the LASIK interface - Numerous plastic particles are generated during microkeratome oscillation and are deposited at the interface during LASIK. The particles persist unaltered for at least 1 year.

Visual symptoms and aberrations - The LADARWave wavefront measurement device is a valuable diagnostic tool in measuring refractive error with ocular aberrations in post-LASIK eyes. 

Ocular Surface Before and After LASIK - Sensory denervation of the ocular surface after bilateral LASIK disrupts ocular surface tear dynamics and causes irritation symptoms.

Pharmacological management of night vision disturbances after refractive surgery: - Diluted aceclidine seemed to be an effective and safe treatment for night vision disturbance following refractive surgery.

Patients Never Really Understand... - “What good is making pupil size measurement a part of the standard of care if it is never utilized (by the doctor, or to communicate to the patient the risks it implies about the surgery they are considering)?"

Hot Compresses Fix Nerve Damage? - "that warm compresses along with other therapies can treat even the worst dry eye patients after LASIK."

Laser Eye Surgery Failure Rate Reported At One In Ten - In 2003, the medical journal Ophthalmology said the failure rate for eye surgery was one in ten, not the one in 1,000 figure widely advertised.

Ectasia known risk of laser vision correction - Ectasia is a known risk of laser vision correction, and if ectasia occurs in a patient following laser vision correction it does not necessarily mean that the patient was a poor candidate for surgery, that the surgery was contraindicated, or that there was a violation of the standard of care.

Floaters - 13% of post-LASIK eyes have posterior vitreous detachment (floaters)! And 25% of high myopes have posterior vitreous detachment after LASIK!

Posterior Vitreous Detachment - Effect of microkeratome suction during LASIK on ocular structures.

Correlations in a change in aqueous tear evaporation with a change in relative humidity and the impact - To establish scientific relationship between relative humidity (RH) and aqueous tear evaporation to elucidate possible significance of this relationship in normals and aqueous tear deficiency patients.

Pressure-induced interface keratitis: a late complication following LASIK - To describe a novel presentation of interface inflammation that resembles DLK in appearance but presents late in the postoperative period, is associated with increased intraocular pressure, and is exacerbated by steroid treatment.

Influence of pupil and optical zone diameter on higher-order aberrations after wavefront-guided myopic LASIK - To investigate the influence of pupil and optical zone (OZ) diameter on higher-order aberrations (HOAs) after myopic wavefront-guided laser in situ keratomileusis (LASIK).

Changes in quality of life after laser in situ keratomileusis for myopia - People presenting for LASIK scored measurably poorer than matched patients not contemplating refractive surgery.

Comparative results of keratometry with three different keratometers after LASIK - This study demonstrates that with common keratometers central corneal power is measured too high after LASIK.

Iris repair after a catastrophic laser in situ keratomileusis complication - This report illustrates the surgical approach to and results of a comples iris reconstruction. The presentation and long-term visual and architectural results (follow-up of 4 years) of the repair of a severe anterior segment injury after entry into the anterior chamber by a microkeratome during LASIK is described.

High Interocular Corneal Symmetry in Average Simulated Keratometry, Central Corneal Thickness, and Posterior Elevation - The purpose of this study was to assess interocular corneal syymetry in average simulated keratometry, corneal thickness, and posterior corneal elevation.

The effect of daily use of brimonidine tartrate on the dark-adapted pupil diameter - To investigate the effect of daily brimonidine tartrate 0.15% on the dark-adapted pupil diameter.

Promises - An insiders journal on the evolution and misinformation of refractive surgery.

An Eye Doctor's Fly in the Ointment - "Dr. X, for every patient you send to our laser center, we'll collect the $5000 and we'll make sure you get back $2000."  "That's an extravagant amount," I said. "Isn't that a kickback?"

Reasons patients recommend LASIK - To evaluate the reasons patients who have had laser in situ keratomileusis (LASIK) recommend it to others and examine the disparity between high levels of satisfaction and patient reports of night-vision symptoms and/or dry eye after LASIK.

LASIK complication: loss of electricity to the microkeratome - This type of unforeseen microkeratome malfunction may result in serious flap or other complications.

LASIK for myopia and astigmatism - safety and efficacy: a report by the American Academy of Ophthalmology

Evaluation of the prophylactic use of mitomycin-C to inhibit haze formation after photorefractive keratectomy - To evaluate the results of the prophylactic use of mitomycin-C to inhibit haze formation after excimer laser PRK for medium and high myopia in eyes that were not good candidates for LASIK.

Keratorefractive Surgery, Success, and the Public Health - "I hope the reader will understand how a patient may have clinically acceptable 20/20 visual acuity in the daytime and still suffer from clinically dangerous visual aberration at night if that patient's visual system must cope with an altered refractive error, increased glare, poorer contrast discrimination, and preferentially degraded peripheral vision.

The Pathophysiology of Regression following LASIK - Part of this study determined that there were significant biomechanical and epithelial effects occurring, and that corneal elastic bowing and epithelium changes could practically account for the inaccuracy of LASIK.

Autorefractometry after LASIK - To correlate cycloplegic subjective refraction with cycloplegic autorefractometry in eyes that have had LASIK.

Bacillus megaterium delayed onset lamellar keratitis after LASIK - To report the history and clinical presentation of a 23-year-old man who developed delayed onset lamellar keratitis in his right eye 2 weeks after uneventful LASIK for correction of myopia.

Hyeropic shift after LASIK induced Diffuse Lamellar Keratitis - Diffuse lamellar keratitis (DLK) is a relatively new syndrome that is increasingly being reported after LASIK. We have observed that a hyperopic shift may be associated with the occurrence of this diffuse lamellar keratitis.

Iatrogenic ring scotoma after LASIK - A 37-year-old ophthalmologist had bilateral simultaneous laser in situ keratomileusis (LASIK) for moderate myopia with astigmatism using the Alcon Summit LADARVision laser; an ablation zone of 5.5 mm was used. Five months after surgery, the uncorrected visual acuity was 20/20 and 20/25 but despite regular corneal topographies, the patient experienced prominent ghost images under photopic and scotopic conditions.

Reverse ptosis-induced corneal steepening and decreased vision after LASIK surgery - To report a patient with a past history of LASIK who had decreased vision and induced corneal steepening after lower eyelid ptosis. Surgical correction of lower eyelid ptosis decreased the corneal steepening and improved visual acuity.

Silence is Golden...for the LASIK Doctors? - As Angry Patients Vent Online, Doctors Sue To Silence Them - An article by David Kesmodel, The Wall Street Journal Online.

When doctors sue to silence - What Are They Hiding?

Let's face it, past and recent articles & studies make a clear case for withdrawal of  FDA approval for the LASIK procedure!

 
Laser Manufacturers: Studies, Letters, & Complaints PDF Print E-mail

FDA MDR on ALCON/Summit Apex Plus - Pupil size issue: Patient has undergone photorefractive keratectomy (prk) at hospital at hospital in a foreign country with a FDA approved laser, i.e. The ApexPlus of the co Summit technology.

FDA Warning Letter - To ALCON Laboratories dated January 18, 2005.

Subject: LASIK, Bausch & Lomb, and TLC, my thoughts - An ex-employee's concern for safety and effectiveness.

From the FDA, Summary of Safety and Effective Data - For the Approval of the Bausch & Lomb Technolas 217A.

What’s really the cause of high retreatment rates? - The debate is growing with one laser (ALCON) squarely in the center.

INTRALASE FS 600 C - Laser System (Model 1), Laser Keratome Recall # Z-0147-3.

FDA Warning Letters - To LaserSight Technologies.

FDA MDR Reports - For problems/injuries by VISX Laser.

VISX - Possible Deception? - VISX reported that 97.7% (84/86) of eyes had UCVA of 20/20 or better at 12 months. These 86 eyes represent only 24.5% of patients. Accountability is reported to be 95.6%, despite the fact that 70.7% (248/351) of patients were labeled “not yet eligible” for analysis at 12 months.

Effect of expanding the treatment zone of the Nidek EC-5000 laser - To evaluate the effect of expanding the treatment zone of the Nidek EC-5000 laser.

Ophthalmologist Sues Laser Manufacturer ALCON - Ophthalmologist, Dr. Sandra Brown is acutely aware of what can go wrong when a surgical laser is applied to someone’s eyes. She waited a long time before consenting to laser eye surgery to correct her own flawed vision.

 
A VERY Interesting Article: PDF Print E-mail

Refractive Surgery – A Ten Year Learning Curve

“Ten years on, LASIK appears to have lived up to its promise, although not for the high refractive errors that had originally been proposed.”

 

“In the case of LASIK, patient outcomes showed that visual outcomes became more unpredictable and unstable as refractive error increased.”

 

Read The Full Story

 
Quotes, Non Peer-Reviewed Articles, and More PDF Print E-mail

Informed Consent 

"What concerns me is that if the person informing the patient is themselves poorly or inaccurately informed then how on earth can consent ever be truly informed?" Dr. Sarah Smith.

AND MORE...

Cleaner LASIK: Is it Possible?

http://www.ophmanagement.com/article.aspx?article=86452

 

This from a doctor who was fined $1.1 Million from the FDA for damaging 125 patients...

IOL calculations after refractive surgery need extra care

http://www.ophthalmologytimes.com/ophthalmologytimes/article/articleDetail.jsp?id=302330

Excerpt:  The topic of  IOL implantation after refractive surgery and power calculations arose a few years ago. However, Dr. O'Brien noted that now this situation is arising on a daily basis in practices as the number of refractive procedures increases each year and as the population ages.  "There has been a question of whether laser refractive surgery is accelerating the development of cataract. This is controversial, but I see it more and more often in my practice," he said. Dr. O'Brien is professor of ophthalmology and director of the Refractive Surgery Service, Bascom Palmer Eye Institute, Miami.  The problem, he pointed out, is that the patients who have undergone refractive surgery and then develop cataract are different in mindset from the traditional patient with cataract in that they have extraordinarily high expectations; they want immediate results; and they want no surgical discomfort, sutures, or downtime after the procedure.

"These patients who develop cataract after refractive surgery want a perfect outcome. They are potentially frustrated and angry because their quality of vision has suffered as the result of the refractive surgery, and the results may be unpredictable. Interestingly, incorrect power is the most common reason for IOL explantation. This is the result of our not being able to determine the power as accurately as we would like," he stated and advised exercising extra care with these patients.

"Successful LASIK" is an oxymoron

Found on Lasik-Flap bulletin board: http://www.lasik-flap.com/forum

The flap never heals. It cannot heal. All it can do is form a scar at the margin of the flap which is only 28% as strong as a normal cornea. The flap itself does not bond to the underlying cornea and can be dislodged or lifted years later.

The corneal nerves that play a vital role in tear production never fully regenerate. A scientific peer-reviewed study proved that at 3 years post-op the corneal nerves are still less than 60% of pre-op densities. LASIK induced dry eyes is common and for many patients is a life-long sentence.

The suction ring used during the cutting of the flap damages the delicate structures inside the eye including the retina, vitreous, and optic nerve. Many patients report increased floaters (posterior vitreous detachment) after LASIK, and some experience retinal tears or detachment, lacquer cracks, macular holes, macular hemorrhages, optic neuropathy, and retinal vein occlusion.

LASIK corneas are not as stable as normal corneas and can begin to bulge weeks, months, or even years later, potentially resulting in loss of the cornea. This bulging is a response to the normal intraocular pressure. A LASIK-weakened cornea sometimes can no longer withstand this outward force. The FDA used a best-guess safety limit of 250 microns of cornea under the flap when LASIK was approved. Since then it has been shown in the medical literature that 250 is not a safe limit, even though the vast majority of LASIK surgeons, who are too busy doing LASIK to follow the research, are still using an unsafe limit of 250 microns. And the FDA does not have the backbone to modify the approval, allowing the LASIK industry to continue this unsafe practice that jeopardizes the well-being of millions of patients.

There is permanent damage in 100% of LASIK corneas -- debris in the space between the flap and the underlying cornea, undulations and microfolds in the Bowman's layer -- presumably because the flap doesn't fit to the altered corneal bed, haze, epithelial cells under the flap, acutely and chronically reduced keratocytes, epithelial thickening, collagen fibril disorganization, collagen lamellar disarray, and abnormalities of the Descemet membrane.

Quote from one peer-reviewed study: "However, the presence of pathologic findings up to 7 years after LASIK indicates that the process of corneal stroma wound healing never completely regenerates histopathologically normal corneal stroma."

Loss of night vision quality after LASIK occurs frequently, according to a 2002 report by the American Academy of Ophthalmology. For some patients, particularly those with large pupils, this complication can be debilitating. Since this is a "frequent" problem after LASIK, I wonder how many of the approximately 8 million Americans who have had LASIK are out there on the roads at night endangering their life and the lives of others who share the roads with them? A recent study showed that up to 50% of LASIK patients are impaired when driving at night. Yet this serious threat to the public health is down-played and swept under the rug by the LASIK industry.

And then we have the problem of the white wall of silence. Doctors are pressured by their peers not to testify for patients who are victims of LASIK malpractice. They are threatened by their own insurance carriers, which could put them out of business. And they are concerned about giving LASIK a black eye by helping a patient seek justice for the harm done to him or her in a public forum like a court of law. They cave in to the pressures, leaving patients without any recourse -- medical, legal or otherwise. So doctors just get away with it and standard of care and informed consent continue to be basically non-existent. And the FDA says it's not their problem (they regulate the devices, not the doctors).

So who's looking out for the patients? Who's going to warn them that 1/3 of their corneas will be nearly sliced off, leaving them with a structurally weakened cornea that can begin to bulge years down the road? Who's going to warn them of the seriousness of LASIK-induced dry eyes, that the nerves never regenerate, and that painful dry eyes can be permanent? Who's going to warn them that LASIK, all LASIK -- conventional and custom, induces higher order aberrations in all virgin corneas, effectively reducing the quality of their vision? Who's going to warn them of the damage the suction ring can do to the structures inside the eye? Who's going to warn them that the flap never heals?

You would think doctors would be protecting patients. Wake up and smell the coffee. Money is what drives them, not a desire to heal the sick. They don't deserve to be called doctors. They are no better than used car salesmen.

American Academy of Ophthalmology. For some patients, particularly those with large pupils, this complication can be debilitating. Since this is a "frequent" problem after LASIK, I wonder how many of the approximately 8 million Americans who have had LASIK are out there on the roads at night endangering their life and the lives of others who share the roads with them? A recent study showed that up to 50% of LASIK patients are impaired when driving at night. Yet this serious threat to the public health is down-played and swept under the rug by the LASIK industry.

Mistakes/Errors

JOURNAL OF REFRACTIVE SURGERY
Vol. 22 No. 3 March 2006  
Dan Z. Reinstein, MD, MA(Cantab), FRCSC; Cynthia Roberts, PhD  

Excerpt:  "Some of the evidence pointing to the impact of corneal biomechanical properties on surgical outcomes lies in the measurement of intraocular pressure (IOP), both before and after refractive surgery. It is well known that measured IOP is reduced, on average, following a refractive procedure. It has been assumed that this is the result of reduced curvature and thickness in myopic procedures. However, Chang and Stulting performed a retrospective review of over 8000 myopic LASIK patients, and determined that although measured pressure was reduced on average by approximately 2 mmHg, the range of change was approximately +10 to -15 mmHg. Every patient in this population had reduced thickness and curvature, and yet almost half of them had an increase in measured IOP.  

Clearly, the artifact in IOP measurement cannot be explained by thickness alone, and “correction” of measured IOP postoperatively using a linear correction factor based on thickness is problematic. This leads to the conclusion that refractive surgery likely alters the fundamental biomechanical properties of the cornea.

Lasers or Surgeons: What's really the cause of high retreatment rates?

http://www.eyeworld.org/article.php?sid=2267

EyeWorld
January 2005

“I had one time where I had to put the flap back with a flashlight because the illumination light went off so I couldn’t figure out where the flap was,” Dr. Rubinfeld said.

Interface fluid after LASIK

J Cataract Refract Surg. 2001 Sep;27(9):1526-8.

Fogla R, Rao SK, Padmanabhan P.  Cornea Services, Sankara Nethralaya, Chennai 600 006, Tamil, Nadu, India. mrf@sankaranethralaya.org  

We report a case in which raised intraocular pressure (IOP) was associated with interface fluid after uneventful bilateral laser in situ keratomileusis (LASIK). The patient presented with diffuse lamellar keratitis in both eyes 3 weeks postoperatively that was treated aggressively with topical corticosteroids. A steroid-induced rise in IOP resulted in interface fluid accumulation and microcystic edema. Measurements with the Goldmann tonometer revealed an IOP of 3.0 mm Hg in both eyes. However, Schiotz tonometry recorded a pressure of 54.7 mm Hg in both eyes. Reduction in the dosage of topical corticosteroid and medical treatment of the raised IOP resulted in resolution of the microcystic edema and interface fluid accumulation. This case highlights the inaccuracies of IOP measurement after LASIK and the resulting complications.

LASIK: three unexpected complications

J Refract Surg. 2001 Mar-Apr;17(2 Suppl):S177-9.  Rosa DA.

PURPOSE: To report unexpected outcomes in three patients after uneventful laser in situ keratomileusis (LASIK) performed using the Nidek EC-5000 excimer laser and the Hansatome microkeratome (Bausch & Lomb Surgical).

METHODS: LASIK was performed with the Nidek EC-5000 excimer laser and the Hansatome microkeratome (Bausch & Lomb Surgical) in three patients.

RESULTS: In three patients, unexpected outcomes were observed. One patient treated for -3.00 D of myopia presented with a central island. One patient treated for +2.00 D (+1.00 x 90 degrees) of hyperopia in both eyes ended up emmetropic in one eye and overcorrected in the fellow eye. The third patient with -12.00 D (-2.00 x 180 degrees) of myopia was treated as -8.60 -1.00 x 180 degrees and at last examination was +4.00 D. During these sessions, all other patients treated were within +/-0.50 D of emmetropia.

CONCLUSION: After LASIK with the Nidek EC-5000 excimer laser and the Hansatome microkeratome (Bausch & Lomb Surgical), unexpected outcomes may still occur, despite controlling all the usual variables.

Oculocardiac reflex in a nonsedated LASIK patient

J Cataract Refract Surg. 2002 Sep;28(9):1698-9.  

Baykara M, Dogru M, Ozmen AT, Ozcetin H.  Uludag University Faculty of Medicine, Department of Ophthalmology, Bursa, Turkey 

A healthy 21-year-old man had laser in situ keratomileusis (LASIK) in the right eye for a refractive error of -7.0 diopters. The electrocardiogram findings and heart rate were recorded before LASIK; during eye lid speculum insertion, vacuum application, corneal flap preparation, and excimer laser keratectomy; and after the procedure.

The pre-LASIK heart rate was 90 pulses/min. Severe bradycardia of 40 beats/min developed during vacuum application, and the procedure was terminated. Severe bradycardia caused by an oculocardiac reflex may occur during LASIK, and patients should be closely monitored during the procedure.

LASIK complication: loss of electricity to the microkeratome during the forward pass

Acta Ophthalmol Scand. 2003 Oct;81(5):530-2.  

Tuominen IS, Tervo TM.  Department of Ophthalmology, Helsinki University Hospital, PO Box 220, HUS, SF-00029 Helsinki, Finland. ilpo.tuominen@hus.fi  

CONTEXT: A 32-year-old woman was scheduled for myopic laser in situ keratomileusis (LASIK) because of myopia and anisometropia caused by retinal detachment surgery.  

CASE REPORT: During surgery, a sudden malfunction of the microkeratome during the forward pass was experienced. It was not possible to reverse the blade manually along the suction ring. Moreover, disconnecting the suction from the control unit did not help at first, because the suction ring was firmly attached to the ocular surface. However, detaching the suction line from the control unit aborted the vacuum and allowed the surgeon to turn the whole microkeratome backwards, mimicking the normal blade movement. Finally, an almost normal flap was observed, and the operation was successfully completed. Afterwards, the wire to the electromotor of the microkeratome was found to be broken and subsequently replaced.  

CONCLUSION: This type of unforeseen microkeratome malfunction may result in serious flap or other complications.

Refractive surprise after LASIK

Arch Soc Esp Oftalmol. 2005 Sep;80(9):547-9. Related Articles, Links

CASE REPORT: A female patient underwent laser in situ keratomileusis (LASIK) in both eyes. The final degree of astigmatism in her left eye was double the preoperative value due to an error in data management. Complex surgery to both eyes was necessary to resolve the mistake.

DISCUSSION: Complications in refractive surgery can occur, however errors in data management must be minimized by double-checking. Solutions to resolve the errors made can be difficult and the entire staff must share responsibility to avoid these undesirable outcomes.

Failure to verify treatment parameters can lead to LASIK errors

http://www.osnsupersite.com/  

TOP STORIES 3/24/2006  

Quote: In the last case, the patient allowed the surgeon to call him “José” several times, believing the surgeon was making a joke. Only after one eye had been treated incorrectly did he clarify his name was “Carlos,” Dr. Sonal said.

Turn Around These LASIK Letdowns

Review of Optometry  

Excerpt:  For most carefully chosen patients, LASIK continues to improve their quality of life significantly. However, the popular media that once portrayed LASIK as a somewhat miraculous procedure now tell horror stories of people visually disabled by LASIK gone awry.  

Read the entire article at:

http://www.revoptom.com/index.asp?ArticleType=SiteSpec&page=osc/oct01/lesson_1001.htm

What's Next for LASIK?

Ophthalmology Management Issue:
September 2004  

Outcomes are better than ever, but its place as the dominant refractive procedure is now in doubt.  By Jerry Helzner 

http://www.ophmanagement.com/article.aspx?article=86168

EyeWorld

December, 2006 -

http://www.eyeworld.org/article.php?sid=3545

http://www.eyeworld.org/images/New_Articles/2006/12/68.jpg

http://www.eyeworld.org/article.php?sid=2765

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"Make sure the first patient you enroll feels like you have been doing this for years..."

EyeWorld October, 2005

Stephen S. Lane, M.D.:

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“There has been a lot of interest in ectasia worldwide because it is a lose-lose situation for both patients and surgeons."

http://www.escrs.org/PUBLICATIONS/EUROTIMES/06Oct/pdf/Riskfactorfor.pdf

However, I believe there are too many holes in available literature reports to allow risk factors to be conclusively defined. Likely, there are other variables that are not measured or that we don’t know how to measure that account for this complication,” said Dr Binder. He added, “Any of the current recommendations for safe patient selection are guesswork and unproven."

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Why do you not use the Excimer laser?

http://www.lcrs.co.uk/menu/FAQ

Other clinics do with very good results, but a higher complication rate. We don't believe in taking additional risks, so we don't operate on the line of sight by cutting across the eye and don't remove any tissue. These are the two main reasons for laser complications. For example, up to 50% of patients permanently lose some night vision, making night driving dangerous and because after LASIK the corneal flap never heals. The cornea is permanently weakened by between 40% and 50% and some cases are require corneal transplants to restore their sight. For more information in LASIK, you can visit www.lasereyedoctor.co.uk or ask for our leaflet: Lasers in refractive surgery.

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Recurrent Regression After Hyperopic LASIK

From Cataract & Refractive Surgery Today, 2003 http://www.crstodayarchive.com/03_archive/0602/crst0602_101.html

Refractive Challenge

By Mitchell C. Shultz, MD Excerpt:

"Through my 6 years’ experience performing refractive surgery, I have found that women in the perimenopausal age group have a significantly increased risk of dry eye syndrome after LASIK when compared to other subgroups of patients. LASIK-induced neurotrophic epitheliopathy (LNE) caused by the transection of the sub-basal nerve fiber bundle and photoablation of the superficial stromal nerves sets the stage for postoperative dry eyes. The combination of LNE and hormonal changes affecting meibomian secretions leads to a chronic tear film dysfunction that is more prevalent in peri- and postmenopausal women. For this reason, I am leery of performing LASIK on these patients."

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http://www.osnsupersite.com/view.asp?rID=23169Eric D. Donnenfeld, MD:

Quote: A 45-year-old woman came in for routine LASIK. I’m doing my LASIK, I hand off the keratome, and they blow out the keratome. And suddenly there is no flap. Now we’re looking for the flap, but we can’t find it. And all of you know how to find out if spaghetti is done. You throw it against the wall. If it sticks, it’s done. And that’s exactly what happened. The cornea ended up against the wall. We find it, but now it’s been sitting on the wall for about 5 minutes. 

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http://www.ophthalmologytimes.com/ophthalmologytimes/article/articleDetail.jsp?id=405941 R. Doyle Stulting MD:

"Ectasia is estimated to occur in one of every 2,500 patients undergoing LASIK, Dr. Stulting said, "but this may be an overestimate because of current exclusion criteria. It also may be an underestimate because of limited follow-up." Reported cases of ectasia have been diagnosed up to 4 years after LASIK, he added, also noting a case of ectasia that required corneal transplantation 13 years after PRK. "Pathology in this case suggests cell loss and abnormalities of keratocytes, leading us to wonder whether defective keratocyte metabolism could make ectasia more likely and to wonder whether mitomycin C might increase the long-term risk of ectasia," Dr. Stulting said."

Analysis of ectasia after LASIK: Risk factors

JCRS Analysis of ectasia after laser in situ keratomileusis: Risk factors Volume 33, Issue 9, Pages 1530-1538 (September 2007) Perry S. Binder

Quote: The mean flap thickness measured at surgery by subtraction pachymetry (n = 350 eyes) was 113.1 ± 29.3 μm (range 29 to 221 μm).  Quote: The RST measured directly after the laser ablation, recorded in 250 eyes, ranged from 102 to 384 μm.

If the eyes in that study had achieved flap thicknesses in excess of 200 μm, which is not uncommon with the microkeratomes used at that time, the residual thicknesses would have been less than 250 μm in all cases.

Correlation Between Attempted Correction and Keratometric Refractive Index of the Cornea After Myopic Excimer Laser Surgery

Journal of Refractive Surgery Vol. 23 No. 5 May 2007 Giacomo Savini, MD; Piero Barboni, MD; Maurizio Zanini, MD Quote:

Inaccurate calculation of intraocular lens (IOL) power after refractive surgery has been the subject of considerable attention in the past decade. It is widely recognized that using videokeratography underestimates corneal flattening after myopic excimer laser surgery. As a consequence, standard keratometric values lead to IOL power underestimation (with subsequent hyperopia) in eyes that have previously undergone myopic photorefractive keratectomy (PRK) or LASIK.1,2

Effect of Punctal Plugs in Patients With Low Refractive Errors Considering Refractive Surgery

Journal of Refractive Surgery Vol. 23 No. 5 May 2007 Monica B. Khalil, MD; Robert A. Latkany, MD; Mark G. Speaker, MD, PhD; Guopei Yu, MD, MPH

Quote: Retreatment rates up to 15% have been reported with conventional LASIK.6 However, retreatment increases risk of complications, such as diffuse lamellar keratitis, epithelial ingrowth, striae, infection, prolongation of dry eye, and flap dislocation. These complications are potential causes of decreased best spectacle-corrected visual acuity (BSCVA).

Role of the endothelial pump in flap adhesion after LASIK

J Cataract Refract Surg. 2004 Sep;30(9):1989-92. Bissen-Miyajima H, Nakamura K, Kaido M, Shimmura S, Tsubota K.

Quote: The mechanism of flap adhesion immediately after surgery is strongly affected by the pump function. In the long term, flap adhesion is more dependent on the epithelium. Pathologic studies of rabbit eyes reveal epithelial hyperplasia at the flap edge.5, 6 Clinically, there have been reports of flap dislocation; however, these cases had evidence of injuries.7, 8 During LASIK enhancement procedures, the edge of the flap is observed to be tightly adhered to the epithelium. Once this tight junction is compromised, the flap can be easily peeled, which underscores the importance of the endothelial pump even in the long term following LASIK.

High Road Ethics for a High-Tech Era

http://www.aao.org/publications/eyenet/200709/feature.cfm

Feature By Miriam Karmel, Contributing Writer

Any physician in practice today can be confronted with a challenging ethical question. But the new technologies of cataract and refractive surgey may present especially complicated—and potentially rewarding—situation.

The dissatisfied patient is nothing new. But last April, following a recent uptick in complaints from angry and disappointed patients, the Academy’s Ethics Committee issued an alert urging doctors to be more mindful of their ethical obligations.

The alert, which is posted here, addressed complaints from patients claiming they hadn’t been adequately informed of the potential visual side effects associated with multifocal or accommodating intraocular lenses. “There’s a perception that experienced cataract surgeons are not increasing their attention to assessment of patient need, and to the learning curve,” said Charles M. Zacks, MD. “That’s resulting in more unhappy refractive patients than ever.” Dr. Zacks, who chairs the Ethics Committee and practices cornea medicine in Portland, Maine, called this “a very big problem. Particularly if patients feel they weren’t adequately informed.”

The prospect for ethical challenges may be especially relevant for the new, high-tech IOLs, but the principles they invoke—informed consent, primacy of the patient’s interest and respect for the learning curve—apply whenever a physician tries incorporating new procedures or technology into clinical practice.

“There’s a lot of new technology in most of the subspecialty fields in ophthalmology,” said Richard L. Abbott, MD, professor of ophthalmology at the University of California, San Francisco. “The challenge, ethically, is which technology to embrace? Where do you draw the line between offering the newest technology over a long-standing proven device or procedure? The bottom line should always be what is in the best interest of your patient.”

More Options Mean More Chair Time

When monofocal IOLs were the only choice, the nature of pseudophakic vision was relatively easy to explain. Now patients have multiple options, which require more discussion and tougher decisions. It’s the surgeon’s responsibility, said Dr. Zacks, to give the patient a realistic impression of what these lenses will and won’t do. Will distance or near vision be important to the patient? How will the patient feel about wearing reading glasses? “Everything’s a trade-off in optics. These lenses can compromise contrast sensitivity and other optical qualities in exchange for multifocality. The patient needs to know the advantages and disadvantages of the lens they’re going to get, in unvarnished terms. Fitting the available technology to the patient is really the goal.

”“If doctors aren’t willing to put time in both before surgery, in terms of education and evaluation, and after, in terms of management to optimize the final result, they shouldn’t be using these lenses.”

Preop hopes meet postop reality. Patients whose expectations aren’t met can be extremely unhappy, said William W. Culbertson, MD, professor of ophthalmology at Bascom Palmer Eye Institute and a member of the Ethics Committee. Take the case of the myopic engineer, a woman in her 50s, who’d been accustomed to taking off her glasses to read the fine print on drawings. Following surgery, her reading varied under different lighting conditions, she could no longer read closely without glasses, and halos put an end to her night driving, said Dr. Culbertson, who saw her by referral. The woman claimed she didn’t know she had multifocal lenses until an optometrist examined her eyes. Perhaps her ophthalmologist had told her, but postoperatively she didn’t recall being told anything about multifocal lenses or their potential optical side effects, Dr. Culbertson said. The point is, she hadn’t been adequately informed of the drawbacks.

“I’m not putting down these lenses,” added Dr. Culbertson, who uses them. “They’re very helpful. But the patient needs to clearly know what’s going on, which takes more chair time,” he said. “You can partially off-load it to brochures and videos and patient counselors. In the end, it comes down to the doctor helping the patient make the best choice and answering all the patient’s questions. If doctors aren’t willing to put time in both before surgery, in terms of education and evaluation, and after, in terms of management to optimize the final result, they shouldn’t be using these lenses.”

New Isn’t Always “Best”

And yet some doctors do regard every patient as a candidate for the new lenses, said Marian S. Macsai, MD, professor and vice chairwoman of ophthalmology, Northwestern University, and chief of ophthalmology, Evanston Northwestern Health Care. She senses “an urgency in the air” to put multifocal lenses into as many patients as possible, as well as an attitude that the cataract surgeon who isn’t using these lenses is behind the times.

Recently, Dr. Macsai heard a doctor say that his goal is “100 percent conversion.” In other words, he would like every one of his patients who comes in with a cataract to walk out with a premium lens upgrade. But these lenses are not for everybody, Dr. Macsai said. There’s no reason, for example, for a doctor to urge multifocal IOLs in a person who doesn’t mind wearing glasses, or for a person whose livelihood depends on driving at night. Similarly, she said, the lenses aren’t suitable for patients who are impaired by other disease, such as age-related macular degneration or diabetic retinopathy, since they lack the visual potential to benefit from multifocals.

When there’s not even a cataract. Then there’s the matter of clear lens exchange. “I’m not sure we should be whipping out lenses of normal people because the technology exists and we want to make money. That’s just not a good enough reason,” Dr. Macsai said. Having said that, she acknowledged a place for them in the armamentarium. “For some patients they’re fabulous. It’s just, ‘Slow down everybody! Make sure we’re doing what’s best for our patients and not our pocketbooks.’”

Physician comfort with the technology. The new technology or device should also be what’s best for the physician in terms of philosophy and comfort level with adopting new procedures. Some physicians adopt new practices more readily than others. “There’s a tension between trying new things, pushing the envelope and what’s safe for the patient,” said Ruth D. Williams, MD, a glaucoma specialist in private practice in Wheaton, Ill. Dr. Williams added that glaucoma specialists, for example, are always trying to think of new ways to do filtering surgery. “When you have a patient in front of you, the question is, ‘We have a gold standard in trabeculectomy, and a gold standard in putting in valves. What are the parameters that make it reasonable to try something else that’s not as proven?’”

In part, the answer rests with personality as well as with responsibility. “Some [physicians] always want to try new things, others want the tried, true and proven. People are different. We need both. Our community needs both,” said Dr. Williams.

Dr. Abbott agrees that some ophthalmologists are greater risk takers than others. “Does that mean they’re doing a better job for their patients? I don’t know. Everybody needs to look within and determine what is his or her own personal comfort level,” he said. “In all cases, however, the bottom line is patient-centered.”

ETHICAL PROBLEM, OR LEGAL?

READ THE FULL ARTICLE

Results of Lasik not always clear - Many angry patients suffer silently with visual defects

By Robert Mitchum | Tribune staff reporter August 21, 2007

Millions of people are estimated to undergo the Lasik procedure each year in the United States at academic clinics, private practices and corporate centers. While the vast majority experience no long-term complications of the surgery, a small percentage find themselves with permanent visual defects that are difficult to treat and hard to live with.

Some of these patients respond in anger; a browse of the Internet will turn up several venomous sites calling for litigation against Lasik surgeons, a horror story from comedian Kathy Griffin and even calls for a ban of the procedure itself. Other patients suffering from post-surgical complications languish in silence, unaware of their options for treatment.

Barbara Berney of Rockford was one of these patients, suffering from a long list of complications after her Lasik surgery in 2001: dry eye, night blindness, dimmed vision and a suite of aberrations, including ghosting, halos and starbursts.

"If you made a list of complications, I'd probably have 70 percent of them," Berney said. "How I can stay sane, I don't know."

After a second surgery did not significantly improve her vision, and after an unsuccessful legal action against her surgeon, Berney decided to start an organization for people in her situation: the Vision Surgery Rehabilitation Network.

Group offers support

The VSRN connects people struggling with Lasik complications with ophthalmologists and optometrists experienced in treating such cases. It also offers a measure of emotional support for people struggling with visual defects.

"I've had a couple people commit suicide, who could not imagine living the rest of their lives seeing the way they see," Berney said.

"You cannot underestimate what loss of vision can do to you, and it's very difficult to get family members and co-workers to understand just how difficult it is. It's like trying to explain the color of milk to someone who's blind."

Lasik surgery involves opening a flap in the surface of the eye and shaving down the cornea with a laser, which can correct both nearsightedness and farsightedness as well as conditions such as astigmatism. While new technologies have improved some of the more troublesome steps in this procedure, some complications remain.

The most serious, according to Dr. Michael Rosenberg, ophthalmologist at Northwestern Memorial Hospital, are infections and ectasia, a bulging caused by destabilization of the cornea. In extreme cases, these complications may be treated with a corneal transplant; however, their occurrence is very rare.

READ THE FULL STORY

Eye surgery leaves many with problems

http://www.newsobserver.com/front/story/721249.html

Of millions of patients, more than a few have serious, lasting complications

Sabine Vollmer, Staff Writer

Millions of Americans have undergone laser eye surgery to correct bad vision, and along with the procedure's popularity something else is coming into focus: its hazards.

Advertising stresses the surgery's safety, and most procedures are successful. Tiger Woods, who relies on keen eyesight as the world's best golfer, pitches it as a quick and painless way to restore sharp vision. Even the U.S. Air Force, long skeptical of the surgery, changed its policy in May to let people who had LASIK apply for pilot training.

But every year thousands of Americans who undergo LASIK are left with chronic pain, dryness of the eyes, distorted night vision and even blindness, according to Food and Drug Administration statistics.

LASIK -- which stands for laser-assisted in-situ keratomileusis -- uses lasers to cut and reshape the cornea. It can improve eyesight without complications, but equipment flaws, a surgeon's error or a failure to screen out patients whose eyes are ill-suited for the treatment can cause the operation to go awry.

The American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery, estimates that only 2 percent to 3 percent of the more than 1 million LASIK surgeries each year are unsuccessful. But Food and Drug Administration records of clinical studies show that six months after the surgery, up to 28 percent of patients complained of eye dryness, up to 16 percent had blurry vision and up to 18 percent had difficulty driving at night.

The Triangle, home to two medical schools, is a hot spot for LASIK; 11 eye centers will perform LASIK on about 8,000 patients this year, according to market research.

One of the leaders is Duke Eye Center, whose LASIK surgeons are among the best-trained and best-equipped in the field. But even surgery at Duke's level has damaged a few patients' eyes beyond repair.

One of those patients is Matthew Kotsovolos, 38, of Raleigh. He was the Duke Eye Center's head of finances and received the surgery for free June 8, 2006. It gave him 20-20 vision but left him with intensely dry eyes and excruciating facial pain. He wakes up with sore eyes every morning, wears special goggles to preserve eye moisture and wonders when the pain in his face will kick in.

"I traded in my glasses for permanent head pain, eye pain and these things," Kotsovolos said, pointing to the goggles.

Nine months after his surgery, Kotsovolos quit his job at the Duke Eye Center, took a 25 percent pay cut and started work as business manager in the Duke University Medical Center's gastroenterology division. He is organizing a support group for LASIK patients with complications.

"It may help inform people that this is a surgery with real risks that are understated by LASIK surgeons," Kotsovolos said.

Alan Carlson, head of the Duke Eye Center, said his experience with LASIK is that complications are rare. Carlson, who did not operate on Kotsovolos, said only a handful of the roughly 6,000 LASIK patients he has treated at Duke since 1996 ended up with problems. The eye center does very well in patient satisfaction surveys, he said.

But Carlson acknowledged that the procedure can cause serious complications.

"It's imperfect surgery in an imperfect world," he said.

How many LASIK patients develop post-surgery complications is obscured by a lack of regulation and reporting. Because health insurers don't pay for LASIK, they generally don't track complications. The FDA doesn't require reports from doctors, and regulatory enforcement has been largely limited to recalling malfunctioning lasers.

Post-LASIK lenses

Evidence of problems is accumulating. Some of the strongest is the growing market for contact lenses designed for people who have undergone LASIK and still have vision problems, some seeing worse than before the surgery. One of the leading post-LASIK lens makers is MedLens Innovations, a Front Royal, Va., company founded in 2000.

Robert Breece, an optometrist and MedLens' president, said his company provides hard contacts to more than 2,500 post-LASIK patients annually and business is increasing about 10 percent every year. Breece said his company serves more than 200 people per year who have been seriously disabled by the surgery.

"I don't get to talk to happy LASIK patients," he said.

By the end of the year, SynergEyes of Carlsbad, Calif., plans to bring to market the first line of contact lenses designed specially for laser eye surgery patients with complications who cannot tolerate hard lenses.

A trial version of the SynergEyes contact lenses have given Paula Cofer, 49, of Tampa, Fla., some relief from dry, itchy eyes and night vision so distorted that she sees up to eight moons.

The specially fitted contacts cost $300 every six months, Cofer said. Contact lenses solution, sterile saline solution, artificial tears and lenses rewetting drops run another $150 to $160 per month.

"Life was very simple then," she said about the 30 years she wore glasses. "Now, it's very complicated."

Limitations of LASIK

Patients with complications are starting to fight back on the Internet and through support groups. Medical research in the past three years has come up with insights about LASIK worrisome enough that some eye surgeons have begun to ease away from the procedure.

"We've learned the limitations of LASIK," said Dr. Stephen Pflugfelder, professor of ophthalmology at Baylor College of Medicine in Houston.

An expert in laser eye surgery for more than 15 years, Pflugfelder is increasingly falling back on an older, less invasive procedure known as photorefractive keratectomy, or PRK, which involves only the surface of the eye.

In the past three years, the number of LASIK procedures at Baylor has dropped from about 70 percent to about 50 percent of all laser eye surgeries.

At Duke, LASIK makes up about 80 percent of all laser eye surgeries. Carlson, head of the Duke Eye Center, is comfortable with that.

"Dry eye hasn't been a big problem," he said.

The university buys the most sophisticated lasers on the market, he said. Patients are screened for risk factors and informed of what they can and cannot expect from LASIK. A surgeon might even do the surgery on one eye at a time.

Those precautions did not prevent Lauranell Burch, a former Duke medical researcher, from suffering a serious complications after undergoing LASIK at the Duke Eye Center.

Burch 47, said that since the surgery March 31, 2004, her eyes sting and burn all the time, her eye tissue is wrinkled like a Ruffles potato chip and her night vision is distorted.

"[The damage] is noticeable and on the front of your mind all your waking hours," Burch said. "There's no escape."

In the winter, she takes an anti-anxiety pill about 15 minutes before she drives home in the dark from her job in Research Triangle Park. She compares the distortions she sees at night, also known as star bursts, to explosions of light without a bang.

Burch cut short her follow-up treatment at Duke, became an avid patients' advocate and started to take on LASIK surgeons on the Internet.

Risks of high volume

All LASIK surgeons make an effort to screen patients, and many turn away patients with obvious risk factors.

But LASIK is essentially a buyer-beware procedure.

In choosing a surgeon, patients are usually advised to go with doctors who perform the procedure most frequently. But with LASIK, That advice can be risky.

Dr. Christopher Fleming, a Cary ophthalmologist and former president of the N.C. Society of Eye Physicians and Surgeons, said patients should beware of LASIK surgeons who perform a high volume of operations.

Surgeons who do 10 or 15 LASIK operations a week tend to contract with optometrists who refer patients, Fleming said. In return, the optometrists, who are not medical doctors, screen the patients and do the follow-up care. Some also receive referral fees.

The emphasis on volume, Fleming said, can draw patients into surgery whose eyes are not suited to LASIK. Patients also end up getting follow-up care from optometrists instead of their surgeons.

Fleming performs no more than one or two dozen LASIK surgeries a year and personally screens patients and does the follow-up care. As a result, his patients rarely have complications, he said.

"When you're high-volume and relinquish part of the care to non-physicians," Fleming said, "you don't have time to be thorough. That can lead to problems."

What deters lawsuits

How many North Carolinians have problems after LASIK is not a public record. Patient complaints filed with the N.C. Medical Board are confidential, and the data are not organized by medical procedure.

Only a few complaints become lawsuits, said Bill Faison, a well-known medical malpractice lawyer in Durham who has represented one LASIK patient in court in the past three years.

What foils most attempts to sue for damages, Faison said, are the costs to mount a legal challenge. Also, carefully worded patient consent forms spell out the risks of the surgery and often require patients to first try to work out their differences with the LASIK center.

"Short of the [LASIK surgeon] being stupid, if it's just a bad outcome, there's nothing to recover," Faison said.

The procedure is safe and effective for many, said Dr. Brad Randleman, a laser eye surgeon at Emory University in Atlanta who has done LASIK on about 1,000 patients over the past five years.

Post-surgical complications such as dry eyes and vision distortions often subside after a few weeks.

"I had nothing but a great experience," said Jim Branch, 55, a Raleigh real estate developer who had LASIK at Duke about five years ago.

Medical research has found that cutting the cornea permanently weakens it. The severed nerves need years to recover and might misfire pain signals. But those findings have not been conclusively linked to lingering complications from LASIK, said Dr. William Bourne, an ophthalmology professor and LASIK surgeon at the Mayo Clinic in Rochester, Minn.

"I don't think we've proven what it is," Bourne said.

A better understanding of what causes the complications is essential to screen patients more effectively and eliminate those at risk, he said.

Kotsovolos said he was considered a good candidate for LASIK. His Duke LASIK surgeon blamed part of his problems on an eye inflammation unrelated to the procedure. Another eye specialist has since diagnosed Kotsovolos with a severe dysfunction of the glands lining the eyelids. The condition is considered a red flag when it is found during screening for LASIK.

Charles Hybarger, a building contractor who lives near Chattanooga, Tenn., changed his mind about LASIK after his wife, Kim, a 44-year-old trained nurse, had an unsuccessful procedure Dec. 21 and the complications triggered a deep depression.

Hybarger wonders whether his wife's rheumatoid arthritis should have eliminated her from having LASIK. Laser eye surgery should not be done on patients with auto-immune diseases.

"I wouldn't let any doctor cut on me unless it's life or death," Hybarger said. "I just wear my glasses and be happy with it."

News researcher Denise Jones contributed to this report.

sabine.vollmer@newsobserver.com or (919) 829-8992

Industry's Influence on Medicine

Cataract & Refractive Surgery Today

July, 2007

http://www.crstoday.com/PDF%20Articles/0707/CRST0707_Letters.php

Michael P. Graham, MD

Orlando, Florida

Quote: ...the leaders in our field have become so corrupted by accepting large consulting fees from industry that they are no longer unbiased sources of information.

Quote: It is a sad step backward for ophthalmology when, due to the corrupting influence of corporate consulting money, I feel anecdotal evidence is more reliable than clinical studies.

Quote: I would implore our leaders to do something about this sad situation. Please stop relying more and more on consulting fees for your income. You may not realize it or want to admit it, but it is having a huge effect on how you conduct your studies and what you say at meetings. It is also having a detrimental effect on our profession, because we now have nowhere to go to get unbiased medical information except to rely on our anecdotal experience. Please stop being drug representatives and return to being doctors. After all, that is why we all went to medical school in the first place.

-

Most "leaders" in the LASIK industry are paid consultants to one of the laser manufacturers. Here's just a small sample of surgeons who are paid consultants:

http://lasik-flap.com/forum/viewtopic.php?t=189

The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest

http://www.journals.uchicago.edu/JLS/journal/issues/v34n1/340105/340105.web.pdf

Daylian M. Cain, George Loewenstein, and Don A. Moore

ABSTRACT: Conflicts of interest can lead experts to give biased and corrupt advice. Although disclosure is often proposed as a potential solution to these problems, we show that it can have perverse effects. First, people generally do not discount advice from biased advisors as much as they should, even when advisors’ conflicts of interest are disclosed. Second, disclosure can increase the bias in advice because it leads advisors to feel morally licensed and strategically encouraged to exaggerate their advice even further. As a result, disclosure may fail to solve the problems created by conflicts of interest and may sometimes even make matters worse.

<>

http://www.aao.org/aao/publications/eyenet/200612/opinion.cfm

Quote: Yet physicians are still influenced by gifts or incentives of minimal value.2 So the take-home message is clear. Disclosure may embolden speakers to introduce even more bias than they would otherwise, and listeners may not be able to discount biased information as much as they’d like.

<>

http://www.escrs.com/Publications/Eurotimes/06february/pdf/ETROUNDTABLE.pdf

Jean-Luc Seegmuller: "I don’t think ophthalmologists should admit their mistakes. It’s too dangerous, and I have seen several too-honest colleagues who were in a very bad situation afterwards, and we have tried our best to take them outside but it was very, very difficult.Admit the mistakes? No. Describe the facts and say ‘I have done that,’ but not say it was good or bad, but rather I have done that and this is the consequence and so it was like that, or the complication is like that. It’s too dangerous to say that I have done this and now you are in a bad situation."

5 Questions with Lucio Buratto, MD

Cataract and Refractive Surgery Today

July, 2006

Excerpt:

"What is the biggest obstacle facing refractive surgery and refractive surgeons today?

In the past, we made similar mistakes around the world. We excited our patients about the possibility of extremely good results, and we treated too many patients (some nonexcellent indications); I would say we treated all (or at least the overall majority) of the patients who entered our respective practices. Not all of the patients we treated were really good candidates for surgery, and not all of them received the treatment with the best machines and technology available. Unfortunately, because we had some bad worldwide results, we received bad publicity in the media.

Therefore, patients may now be skeptical about refractive surgery. I know for sure that when I have the right patient, I can give them excellent results. Patients do not always trust the surgery or the surgeon anymore, because we promised too much in the past.

What advice do you have for new surgeons, with regard to managing their patients' expectations and outcomes?

I would tell them to do less business and to take care of the patients they currently have. Unfortunately for many refractive surgeons, when they see a patient, they see dollars in their eyes and not a professional opportunity to improve quality of vision and life for their patient. It is not the same way for a cataract surgeon or a retina specialist, but it is a typical approach of a refractive surgeon. They should focus more on their patients and less on their incomes.

Read the entire article

Admit Mistakes, keep good records to protect against malpractice suits

http://www.osnsupersite.com/view.asp?rID=18043

OSN SuperSite Top Story 8/16/2006

BOSTON — Keeping detailed patient charts, documenting informed consent and accepting responsibility for errors when they occur can help refractive surgeons avoid costly malpractice suits, according to two attorneys speaking here.

"Patients lose trust with their doctor if their doctor minimizes or ignores their problems. Physicians should be aware of this, because if patients lose trust, they will look for other doctors or find their way to a plaintiff lawyer," said Greg K. Zeuthen, a plaintiff attorney.

Mr. Zeuthen and Kevin E. Oliver, a defense attorney, discussed the current medicolegal climate in refractive surgery in two keynote lectures at American Society of Cataract and Refractive Surgery Summer Refractive Congress. They outlined LASIK cases they have handled in court and possible approaches surgeons could employ to avoid litigation.

Mr. Oliver said he tells doctors to imagine a hypothetical situation in which all their charts have court exhibit stickers on them. He then asks them to carefully consider whether those charts are well-documented and adequately clear to be used in a defense or a prosecution.

"You need to chart everything," Mr. Oliver said.

Mr. Zeuthen noted that draconian documentation is the key to minimizing the risk of legal action. Should a case go to trial, it is also important for mounting a defense.

"Paranoia is not bad at all," Mr. Zeuthen said. "It's just a higher state of awareness. If you practice medicine with a higher state of awareness, you're going to avoid more lawsuits."

Both lawyers noted that surgeons should be honest when dealing with refractive surgery mistakes or errors. Most refractive surgery patients are highly educated individuals who understand the legal system and will sue if not treated appropriately, they said.

"It's how a bad outcome is dealt with in your office that determines whether a patient will go to another doctor of to a plaintiff's lawyer," Mr. Zeuthen said.

<>

EyeWorld

June, 2000

http://www.eyeworld.org/article.php?sid=1180

Quote: When it comes to dealing with the unhappy patient, the temptation may be for the practitioner to deny that a result is less than optimal or to avoid the patient altogether.

Quote: Maloney spends a half-day a week just dealing with patients with LASIK complications who have been sent to him on referral. "It's difficult, because generally they don't get to me until there has been some fracture in the relationship with the surgeon," he said. If he can, Maloney reassures the patient that the surgeon didn't make any mistakes.

<>

EyeNet Magazine

February, 2007

Excerpt:

Quote: But what about the patient who is the victim of a medical error?

Most risk management experts, including those at OMIC (Ophthalmic Mutual Insurance Company), recommend immediate and full disclosure of the error, as soon as the patient is able to understand.1 What is not as widely practiced is a heartfelt personal apology to the patient by the physician. An editorial by the chancellor of the University of Massachusetts Medical School, Aaron Lazare, MD, is well worth reading.2 Considerable literature has now accumulated showing that, where it is practiced, disclosure of errors and an apology to the patient has actually reduced the number and cost of malpractice claims. According to Dr. Lazare, there are four parts to an effective apology: acknowledgement of the offense (who, what, where); an explanation of the circumstances bearing on the offense (why); an expression of remorse, shame, humility and a commitment not to repeat the offense; and finally reparation (which could include early scheduling for next appointment, cancellation of the bill, etc.). Not all four parts need be present in every case for an apology to be effective, but an ineffective apology can usually be traced to omission of at least one part.

How do apologies heal? To understand this, it is helpful to examine how a patient feels when he or she learns of a medical error. They often express humiliation, “I was treated like I was on an assembly line,” powerlessness, lack of validation of emotions, the feeling that they were somehow at fault, and, not surprisingly, concern that the same thing could happen to someone else. The longer those feelings fester, the more difficult they are to mitigate through apology. But a prompt and proper apology can make the patient feel cared about by the physician, whose self-humbling has leveled the emotional field between them. Showing a patient how their experience will lead to changes in procedure to avoid recurrence restores their sense of power. Validation of the reasonableness of the patient’s feelings about the error is also helpful in reducing their amplitude.

Read the full article

 
The Threshold Concept PDF Print E-mail

Most traits we can measure in humans vary continuously. Like blood pressure. Blood glucose levels. Corneal thickness. Plot the measurements you obtain for any such trait across enough individuals and you obtain a bell curve. Individuals at the extremes of the bell curve are more rare... and if the measurement you're making is a physiological measurement, there may be a disease process associated with occupying the extremes of the bell curve.

Extremely high intraocular pressure may mean glaucoma.

Extremely thin corneas may predispose to ectasia.

The threshold concept: there is a certain physiological value or threshold, when crossed, results in disease symptoms.

LASIK patients, on average, have lost more than 40% of their corneal nerve density 3 years after LASIK. This may leave a young male, who is in a low risk group for dry eye asymptomatic, while a middle aged female who has lost a similar % of her pre-operative nerve density may experience debilitating dry eye.

Same situation with contrast sensitivity. All patients lose contrast sensitivity... depending on age and other factors, not all of them experience this loss as disabling/debilitating.

An important point is that all patients who have LASIK lose some visual and neural reserves. This means as they age they may cross the threshold to a symptomatic and/or disease state sooner.

People who never would have lost their ability to drive at night or enjoy comfortable vision may lose these abilities at middle age or even sooner because of laser eye surgery.

The point is that refractive surgery has robbed millions of their visual and corneal nerve reserves.

Millions of Americans have been pushed nearer the threshold for dry eye, loss of functional night vision, and corneal failure (ectasia).

 
The Eyes Are The Windows To The Soul PDF Print E-mail

Contributed with permission by Meredith Perry

The eyes are the windows to the soul. And the relatively new LASIK procedure supposedly can make those windows crystal clear.

This quick and painless procedure produces perfect vision.

LASIK surgery has helped millions of people see clearly, yet for a small, but growing number of patients the procedure has not helped, but hurt. For Dominic Morgan the surgery seemed like a dream come true -- but turned out to be a nightmare.

Read more...
 
An Eye For An Eye: Professor O'Reilly Speaks Out PDF Print E-mail

I wish to acknowledge with much appreciation for contributing with permission to post on this site by Professor James O'Reilly the following study on Lasik liability exceptions:

E-Text Version of article published in 71 Univ. Cincinnati Law Review 541 (2003), copyright Univ. Cincinnati 2003  AN EYE FOR AN EYE:

FORESIGHT ON REMEDIES FOR

LASIK SURGERY’S PROBLEMS  Prof. James O'Reilly1

SUMMARY:

... Laser eye surgery is remarkable. ... " The FDA requires device sponsors to report the number of patients who seek a second LASIK procedure to improve vision after the first surgical results were inadequate, but "no laser company has presented enough evidence for the FDA to make conclusions about the safety or effectiveness of enhancement surgery. ... Night vision deficiencies are "one of the main challenges" to improving laser eye surgery. ... The bold and attractive promises being made in LASIK advertising by eye surgery marketing corporations, some of whom are publicly traded entities, may give rise to express warranty claims as well as claims against the individual surgeon or the surgeon's corporate entity as conventional malpractice claims. ... The FDA has jurisdiction over the advertisements for a prescription medical device and, although the FDA requires that warnings be stated for prescription drug ads made to consumers, it does not require the same communication about risks in LASIK advertising. ... The injured LASIK patient's compensation claim against a LASIK device maker is likely to be barred by the Supreme Court's interpretation of the Food Drug & Cosmetic Act to prevent state verdicts asserting design defect claims against FDA- approved medical devices. ... 

TEXT:

[*541]

   I. Introduction

   Laser eye surgery is remarkable. Never before in American medical history have 3 million people each year responded to massive advertising by paying for an innovative, elective surgery. Never before have surgeons competed so vigorously on price; and never has a surgery been so skillfully isolated from liability lawsuits. If LASIK eye surgery becomes the Mass Tort of 2025, will Americans regret accepting it as the benign 20/20 solution of today?

   The first decisions in a series of liability suits against LASIK surgeons have been reported, with one plaintiff receiving a $ 4 million verdict. n1 Yet, the procedure is too new for a body of reported appellate precedent, so this review must be a forward-looking prediction of future judicial behaviors. This article examines the conundrum that an injured LASIK patient, whose vision deteriorates several years after the surgery, may be unable to find a viable defendant, thus leaving the customer without an effective remedy.

   II. Understanding the Context

   What is LASIK Surgery?

   Open your eyes, read a newspaper, watch a television, see a billboard, and elective surgery advertising hits your eye. From thousands of dollars down to hundreds, the competition to sell this mass volume elective surgical procedure has driven down prices. The specific service that was to be provided to an estimated 3,135,000 patients in 2002 is LASIK. n2 LASIK is the acronym for "laser in- situ keratomileusis," a form of computer software-guided cutting of the cornea in the eye using [*542] laser light beams. LASIK and other eye surgery procedures n3 flatten the central curvature of the cornea of the eye, with a flap of skin peeled back in order to effectively alter the ability of the eye to see without external spectacles or contact lenses. A Pennsylvania court summarized the mechanics of the LASIK process in a succinct summary:

   During the LASIK procedure, after the surface of the eye has been anesthetized by eyedrops, a microkeratome is used to create a flap in the outer layer of the cornea which is folded back to allow an excimer laser access to theexposed corneal surface. Computer-controlled laser beams then remove thin layers of corneal tissue to reshape the curvature of the cornea so that visual images will focus directly onto the retina, thereby improving visual acuity. The corneal flap is returned to its original position without utilizing sutures, and a protective "bandage" contact lens is applied to prevent the eyelid from rubbing against the eye surface as the outer layer of cells regrow and the flap re-adheres. n4

   Measurement of the eye and setting the correct parameters into the computer- controlled laser equipment appear to be the principal determinants of surgical success. An experienced surgeon can perform many surgeries in the same day by using the staff of an outpatient surgery facility to prepare the patient. Though the equipment is constantly being improved, the computer controls depend on the accuracy of the data being fed into the system by a skilled surgeon during the pre-surgical evaluation of the patient.

   The reader may choose to read more of the technical details of the surgery elsewhere. n5 This paper will deal with LASIK, but some of the issues are relevant to other processes. Relative to older forms of such refractive surgery, LASIK does not appear to produce greater glare or halo effects during the early stages after surgery. n6 However, the long-term consequences of LASIK are still unknown.

   Is LASIK Surgery Safe?

   As with any surgery penetrating through body tissue, cells are affected by the cutting of corneal tissue. The eye cells heal differently with [*543] different patients whose personal health and other characteristics will affect recovery. In the event that slowly-developing cellular changes in the cornea may cloud the vision of LASIK patients in future years, we simply do not know how a LASIK procedure's adverse effects will manifest themselves. An experience base of five or more years may be needed to follow the progress of patients whose corneal cellular changes are manifested by slow blurring of the vision or the appearance of nighttime glare effects that hinder their ability to drive. This poses the same causation challenge that lawyers experience in other medical delayed-effects situations: the manifestation of eye deterioration attributable to the cutting of cells may be hard to differentiate from deterioration attributable to the effects of normal aging or of unrelated eye problems. For the short term, LASIK appears to be safe, with a small number of adverse effects, as discussed later in this article.

   Why Is LASIK Different from Other Surgical Procedures?

   Surgery is typically a drastic interventional response to a medical emergency or to the failure of an organ or bone system. Any surgery carries risks, especially the in-patient surgery that involves the risk of hospital-related infections. The development of skilled surgical techniques involving micro-surgical interventions has made American surgical capabilities well respected around the world.

   But not all surgical interventions respond to health necessities. Persons who find contact lenses annoying or spectacles inconvenient are being pressed to "try the safe and affordable alternative: LASIK." n7 Americans are willing to pay for various types of elective surgery for anatomical flaws and cosmetic defects. Because the word "cosmetic surgery" draws angry rebukes from eye surgeons, the LASIK processes can at best be called "improvements on nature," rather than the classic use of surgery for a needed remediation of injuries. The wave of 3,300,000 annual LASIK procedures in the United States may be the greatest volume of surgical procedures ever voluntarily undertaken by consumers in the history of medicine. n8

   The sales target for expanding LASIK is thirty-five percent of the 180 million Americans who may need vision care. n9 Of course, such a goal is ambitious, and it amplifies the concern that even a small percentage [*544] of damaged eyes might mean that tens of thousands lose their optimal eyesight as a result of flawed surgery. The market's size is great and the potential downside for a fraction of that population could produce substantial damages. One symptom of the fluid nature of change in this marketplace is the way in which the manufacturers earn their profits: new eye lasers, once approved, are leased to surgeons in return for a per-surgery fee, with new equipment emerging continually in a hot, competitive climate.

   III. The Regulatory Context

   FDA's Twelve-Month Norm

   A traditional question arises again: how much of a database of safety experience should society demand before a new technology is "safe enough" for use on humans? The Food and Drug Administration (FDA) has statutory jurisdiction over medical devices. n10 The FDA has used this authority to specifically approve numerous laser devices for surgical use on the eye. n11 So, it would then seem that the consumer expects to be fully protected by prior government approval before the LASIK device enters the competitive marketplace.

   But, the human clinical studies of comparative surgical results, needed for FDA approval of a new laser eye device, are only required to study patients in the small test sample for twelve months post-surgery. Some studies go to twenty-four months, continuing after the approval of the new device. n12 The laser device maker must supply extensive information about the machine from which the FDA can evaluate the safety and efficacy of the design, and these "premarket approval applications" can be voluminous. n13 But the experience base is relatively short and cannot be expected to catch long-term deterioration effects on the eye, if such effects occur. This does not mean LASIK is going to be found to have a higher risk than we now expect-we just do not know. If ill effects do not arise among the three million customers per year, then a definitive risk conclusion can be made at some future date.

   [*545]

   A review of the FDA website's summaries of product safety for the approval of new laser devices n14 consistently shows that manufacturers submit, and the FDA grants approval based upon, twelve months' experience with the new laserdevices. The FDA examines both the adverse events reported during the twelve month post- surgery follow-up and the complications from surgery reported by the surgeons. The FDA's Office of Device Evaluation in the Center for Devices & Radiological Health then makes a decision about the product's acceptability. n15

   The protection of LASIK surgery patients by the regulatory intermediary, the FDA Office of Device Evaluation, is premised on experiences of up to twelve months post- surgery. By its own public admission, the post-approval examination of medical devices "is not working well." n16 The FDA requires device sponsors to report the number of patients who seek a second LASIK procedure to improve vision after the first surgical results were inadequate, but "no laser company has presented enough evidence for the FDA to make conclusions about the safety or effectiveness of enhancement surgery." n17 Possibly, vision effects may be manifested after a longer period, as reports slowly arrive that demonstrate evolving patterns of experience with clouding of vision as cells change. Such effects might be noticeable after several years have passed: for example, when a patient changes eye doctors and complains about the results promised by an earlier eye surgeon who sold a LASIK procedure as the ideal solution for that person's desires.

   In the liability claims context, the time of reported effects becomes significant. Corneal surgery of various types has a long history, but LASIK's laser/computer interface combined with mass marketing isa relatively recent novelty. A few warning flags are visible in the medical literature, n18 but no one can reliably predict the percentage of ten or twenty-year post-surgical experiences that will be adverse for LASIK patients. It may be that LASIK produces no adverse long- term effects. [*546] On the other hand, LASIK might cause a more rapid and serious cellular degeneration than other causes. The nexus of uncertainties regarding cellular change, rates of deterioration, the value of a twelve month pre-approval study as a predictor, and patient intolerance of vision problems, make for an intriguing challenge to the would-be tort plaintiff.

   How are the Surgeons Regulated?

   The FDA has no jurisdiction over physicians such as the surgeons who use the laser equipment. n19 The FDA requires adequate labeling for proper use by physicians n20 but cannot police the physicians themselves. Surgeons' performance is left to the state medical boards n21 and to the private malpractice system. n22

   The FDA tracks post-approval rates of injury under its Medwatch program of voluntary adverse effect reports on medical devices, n23 as explained on the FDA's Center for Devices website. n24 The surgeon who finds a malfunctioning LASIK device could file a report online with the Medwatch system but is not required to do so. Congress responded to complaints by manufacturers and hospitals, severely restricting the FDA's medical device user reporting authority n25 in the 1997 amendments to the device statutes. n26

   IV. The Liability Context

   Identifying Causes of Action

   At the rate at which LASIK surgery is being sold to new patients, even a small percentage of vision loss claims-a fraction of the millions of cases-could produce a significant volume of potential tort suits. This is a statistical certainty, since the smaller occurrence of adverse eye [*547] effects would become manifest slowly, as the several millions of LASIK recipients age during the years since their eyes were cut by the surgery. n27

   The classic tort negligence test requires a showing of foreseeability of the injury and fault by the responsible product manufacturer or physician. Modern strict liability imposes a compensation obligation on the manufacturer of a defective product regardless of fault n28 and leaves malpractice law to remedy the problems caused by the professional user of the device. Strict liability shifts the costs of injury to the designer and marketer of the product that caused the injury, without the need to show fault or even proof that the injury was foreseeable. n29

   However, strict liability is a policy that carries an important exception-it does not apply if the product offers a special societal benefit like a rabies vaccine or an important pharmaceutical to cure cancer. n30 These latter products were deemed by the creators of modern strict liability to be "unavoidably unsafe," and, thus, subject only to negligence law norms in order to prevent the advance of medical progress from being retarded by the costs of strict liability. n31

   The Third Restatement Shield

   One of the controversial aspects of the 1997 adoption of the Third Restatement of Products Liability was the virtually complete shield from strict liability for prescription drugs and devices that have any beneficial effect for any class of patients. n32 The concept holds that with the existence of a class of patients that will benefit from the device, the device can be sold for all other classes as well and will be immune from the strict liability analysis. n33 For example, leprosy is rarely encountered among United States residents, but a drug that was beneficial to leprosy [*548] patients would not be vulnerable to challenges against its marketing for some other medical indication, such as cancer. The express predicate for this exclusion from strict liability was that the FDA "adequately review(s) new prescription drugs and devices, keeping unreasonably dangerous designs off the market." n34 If one believes the FDA achieves this goal, the Third Restatement makes sense.

   Eye laser devices benefit from the protective shield that the Third Restatement seeks to apply to prescription-only products. Arguably, the availability of laser surgical devices benefits some patients whose eyes are medically impaired and for whom the corneal surgery has a therapeutic purpose. A contrary argument can be offered, however, that three million annual uses of a surgical tool for appearance and aesthetics far outweigh the smaller number of uses of these devices for cases of real medical necessity.

   The Case of the Disappearing Defendants

   In the event that even a small number of LASIK patients experience eye difficulties later, a small fraction out of three million customers each year is still a substantial population of potential plaintiffs. A significant concern for these plaintiffs is that tort law lags far behind laser technology. Lasers are improved each year, but liability systems lag behind, so no compensation for injury may be available to the LASIK customer at the time when a belated manifestation of injury to the eye is diagnosed. If vision clouding problems appear, there may be no financially responsible defendant available against whom a plaintiff can obtain sufficient recovery. This is a particular problem when the longer-term cellular effects of today's LASIK eye surgery manifest themselves years after the surgeon has been paid.

   In part, this tort liability phenomenon of "no viable defendant to sue" reflects business practices that emphasize the very short term orientation of the coverage of malpractice insurance for ophthalmic surgeons. The malpractice insurance industry seems well protected by its preference for "claims-made" policy coverage, the dominant form of new coverage. Such coverage pays claims made during the years for which the insurance was in force. The coverage would not shield the individual surgeon when a claim about delayed corneal blurring effects is made long after the brief LASIK operation is over. This makes a difference for the plaintiff because the absence of an insurance carrier diminishes [*549] the prospects that the plaintiff will ultimately receive damages after a favorable judgment.

   V. The Medical Context

   What Long-Term Issues Exist After LASIK Surgery?

   LASIK is widely performed worldwide "despite the absence of thorough data on the healing response and long-term complications at the tissue level. Clinically visible complications . . . are relatively well known, but the underlying cell biology of these phenomena is less well understood." n35 One study found a loss of cells in a layer of the eye beginning six months after surgery, but the cause of this diminution is unknown and requires further research. n36 Corneal haze of several types "may degrade the retinal image" and more research is needed about its clinical impact. n37 These concerns are more long-term; issues concerning the flap of corneal tissue cut in the eye are among the near-term concerns of eye surgeons, as illustrated in American Academy of Ophthalmology publications. n38

   A frequently cited challenge for surgeons is "irregular astigmatism." When the same eye has been subjected to multiple laser surgeries to improve on conditions initially reported by the patient after surgery, "corneal stability in the long-term is still a worrying factor," and in individuals with a major degree of irregular astigmatism, loss of visual acuity is permanent and symptomatic. n39 Not all irregular astigmatism can be corrected; careful patient selection is often recommended. n40 The LASIK technique is too new for surgeons to understand the natural history of future effects of "central islands" on the cornea, which cause numerous detrimental effects. n41 For the estimated 165,000 photorefractive keratectomy (PRK) procedures done annually, "visually debilitating corneal haze may persist in approximately 5% of all PRK [*550] patients." n42 Enhanced cellular reflections from high numbers of wound healing keratocytes are an important contributor to haze, and drugs may be useful to aid clarity of vision after PRK. n43 Night vision deficiencies are "one of the main challenges" to improving laser eye surgery. n44 Corneal scarring and keratectasia, or dilation of the eye, were a particular issue with patients who had multiple LASIK surgeries, with cautions for surgeons about third and fourth retreatments of the same eye. n45 A Utah researcher/surgeon noted the "paucity of peer review literature" to substantiate LASIK's safety and efficacy and expected in a 1998 article that better computer software would reduce the percentage of patients who required retreatment-which was then at about thirty percent. n46 We simply do not yet know enough.

   VI. The Litigation Context

   Are Long-Term Effects Actionable?

   If a patient is dissatisfied with the resulting vision after LASIK, a second surgical procedure may be offered, but the literature cautions about more serious consequences with each successive cutting of the eye tissue. n47 Corneal perforation is rare, but other potential complications include ingrowth of the epithelial layer, infection, severing of the flap of skin cut in the cornea, wrinkling of the flap, and corneal astigmatism. n48 The longer-term effect of the surgery on cellular changes in the complex tissues of the eye is being studied, but time will tell whether the current favorable view of the surgery is altered by future studies showing eventual degradation in vision in a LASIK population compared to an uncut-cornea "control group." As of now, evidence is unavailable. There are indications that the collective profitability for surgeons performing the procedure may inhibit other doctors from rendering [*551] critical second opinions about LASIK. n49 Regardless, the cases that have reached litigation have involved a variety of vision impairments, including disabling impairments for persons who need excellent night vision, such as pilots. n50

   Whether the individual's impaired vision effects are worth litigating is a matter of judgment for the patient and counsel. The contingent fee system makes the plaintiff's counsel somewhat reluctant to challenge multiple defendants on a cause of action that does not yet have substantial case law illuminating the duty and liability of the manufacturer and surgeon. The population of persons paying for this elective surgery tends to be somewhat more affluent than average patients, and for some of them, perhaps a later experience of complications will stimulate the search for legal relief on a fee-paid hourly basis. Counseling such a client to initiate damages litigation involves a number of considerations, including the unavailability of insurance carriers for claims that are made several years after the surgery.

   The causes of action would include defects in LASIK equipment design, defects in the knife-like microkeratome used to slice the cornea, failure to adequately communicate risks to the patient, failure to adequately warn of the long-term effects observed in the LASIK medical literature, and, perhaps, claims of breach of express warranty that the procedure is "safe" for the eye of the patient. The bold and attractive promises being made in LASIK advertising by eye surgery marketing corporations, some of whom are publicly traded entities, n51 may give rise to express warranty claims n52 as well as claims against the individual surgeon or the surgeon's corporate entity as conventional malpractice claims. n53 Safety advances in the design of machines for laser eye surgery [*552] may have reduced the adverse effects that would have been seen with the earliest LASIK equipment, though an insufficient time has passed to form reliable statistical projections. An elaborate publicity campaign against criticism of LASIK has been launched by a trade group, funded by manufacturers using a national public relations firm. n54

   Plaintiffs confront numerous barriers, including the Daubert standard, n55 which allows equipment makers and surgeons to exclude the testimony of a critic of the LASIK device's use if that critic had not passed the scrutiny of pre-trial screenings. A climate for product design liability regarding inadequacy of pre-market testing of the machines may exist when future claims are brought. The makers of the expensive laser equipment are rapidly altering and upgrading their machines and software as the marketplace demands rapid responses to competitors' innovations.

   What Barriers to Recovery Exist?

   The first barrier to recovery will be time: if the now-reasonable balance of risk data and effectiveness were to shift against LASIK after five to ten more years of experience, the patient with blurred eyes must establish a causal connection to his or her present condition. The complexity of medical proof of causation would be formidable because many post-surgery events might have triggered the harm.

   Time also affects the viability of a damages claim by the impact of the statute of limitations on the ability of a plaintiff to sue for an effect that became evident long after the laser surgery was completed. A cause of action would arise either when the surgery was performed or when the plaintiff discovered the connection between the surgery and the plaintiff's presently deficient vision. Plaintiffs could claim that they sued within a reasonable period after discovering that a tort had been committed, this "discovery rule" in torts would halt the tolling of the statute of limitations. n56 But, the degree to which any belated discovery of blurred vision can be tied to knowledge of the surgery-injury connection will be very fact-specific. This is not an easy issue for the plaintiff to reopen, several years after surgery. State medical [*553] malpractice procedures form an additional barrier against the potential plaintiff's recovery. n57

   Effects of the Malpractice Crisis

   The second barrier will be a likely absence of malpractice insurance as a force for settlement. An immediately observable injury tied to malpractice can produce a sizeable claim and a large settlement, as demonstrated in a recent Colorado case. n58 But, LASIK's cellular effect on the eye, if it occurs in a patient, will take time to develop.

   Timing is everything when insurance coverage is at stake, and here it will be central to the plaintiff's attorney selecting the right contingent fee case to accept. There has been a significant rise in the use of "claims-made" malpractice policy forms, under which most medical malpractice carriers decline to pay claims that have not been presented to the insurer during the contract term or within a short "tail" thereafter. n59 This type of surgical malpractice policy contrasts with the "occurrence" policy covering the acts of the surgeon during the entire policy period, even if the claim is made after expiration of the policy years. n60

   The severe lack of profitability is driving some insurance carriers out of the medical malpractice insurance market. Aggregate 2001 industry statistics n61 show that about $ 10 billion was spent on health care malpractice insurance mechanisms in 2001, of which $ 5,586,584,000 was in insurance premiums. Loss ratios rose to 74.4% in 2000 from 54.3% in 1997. It is estimated that the malpractice insurance carriers' combined ratios of loss and expense exceeded 133% of the insurance carrier's income from premiums at the same time that income from [*554] investments was diminished by stock market declines. St. Paul Insurance Company quit the medical malpractice insurance market when its losses became too severe: in 2001, the major malpractice carrier lost $ 940,000,000 on medical malpractice coverage and halted all future policy renewals or new policies. n62

   If an adverse eye effect is only manifested some years after the surgery, the physician's carrier will decline coverage because the patient's vision deterioration claim was not presented to the carrier during the contract period of the "claims made" policy. The plaintiff is able to continue the suit against the corporate or individual entity that performed the service, but the likelihood of a major settlement payment diminishes without the presence of an insurance carrier at the negotiating table.

   Once the plaintiff's lawyer learns that no insurance coverage exists for the belated claim, the corporate structure of the eye surgeon becomes very important to the plaintiff's recovery efforts. n63 The corporate structures used to protect the surgeon's own assets in an LLC or professional corporation may have been dissolved by the year when litigation begins. The surgeon is quite likely to have imprinted the corporation's name on the documents to protect the surgeon's personal assets. Propensity of the LASIK surgeon's competitors to cut prices n64 and to reduce overhead leaves less residual cash for an insurance or loss reserve within the surgeon's LLC. In short, there may be no viable defendant left by the time the plaintiff determines that LASIK caused the vision problems.

   Effects of Consent

   Consent forms present the third barrier to the plaintiff. The attractive models in the LASIK advertisement and the terrific price claims for throwing away one's glasses will inevitably receive more visible space in advertisements for LASIK than the comparable visuals receive in prescription drug advertisements. That is because the surgical consent forms that contain the warnings only need to be presented at the time [*555] the buyer pays for the service. The FDA has jurisdiction over the advertisements for a prescription medical device and, although the FDA requires that warnings be stated for prescription drug ads made to consumers, it does not require the same communication about risks in LASIK advertising. n65

   The drafting of a surgical consent form is an art, at which defense counsel should excel. Surgeons have listened carefully to their defense counsel. If a LASIK surgeon is sued, the defense will argue that an ironclad consent form was executed by the plaintiff. The consent forms for laser eye surgery may be an extreme readability test for people who have selected one among several competing vendors for cheaper, faster and more efficient service for their eyes. The savvy surgical staff always has "one more form" to hand the patient to be signed. The person who has elected to get the surgery has probably signed the credit card receipt before signing all the other forms, including the surgical consent forms. The buyer of high volume elective surgery may be unaware that among the routine paperwork, the customer is signing away future rights by failing to focus on the consent forms. Breaking through this barrier to attack the failure to adequately warn will be a major inhibitor upon the willingness of the plaintiff's bar to take these cases on a contingent fee basis.

   Effects of Preemption Defenses

   The reader may expect that, even if the surgeon escapes liability, the device manufacturer is still an available defendant for a compensation claim. Alas, preemption of state tort recoveries by federal statutes is the fourth barrier to be faced by an injured customer. The United States Constitution permits Congress to govern interstate commerce. n66 Congress responded to a concern about medical device safety by regulating the interstate sale of medical devices. n67 At the time the specific authority to approve new medical devices was delegated to the FDA, Congress answered the device manufacturers' pleas by prohibiting the states from adopting "requirements" for medical devices that differed from federal "requirements." n68 In the 1976 Medical Device [*556] Amendments, Congress preempted states from imposing medical device requirements that are in addition to or different from federal medical device approval requirements. n69

   In two cases, the United States Supreme Court has interpreted the device legislation to shield virtually all manufacturers of innovative medical devices. The injured LASIK patient's compensation claim against a LASIK device maker is likely to be barred by the Supreme Court's interpretation of the Food Drug & Cosmetic Act n70 to prevent state verdicts asserting design defect claims against FDA- approved medical devices. n71 The plaintiff in a LASIK case against a manufacturer must overcome the legacy of the device industry's landmark victory in the 1996 Supreme Court decision Lohr v. Medtronic, Inc. n72 when combined with both the industry's successful effort to win 1997 amendments to the FDCA n73 and the 2001 Supreme Court industry victory in Buckman Co. v. Plaintiff's Legal Committee. n74 These efforts have collectively slammed the door on most causes of action for defective design of a medical device. n75 Suing the LASIK equipment supplier will be unlikely to succeed if the claim is related to design; claims of inadequate warning might also be blocked both by the FDA's specific product labeling approval n76 and by the patient consent forms, considering the breadth of wording in the pre-surgery consent documents that are routinely signed by LASIK patients.

   Effects of Market Volatility

   Finally, the medical device market is both global and volatile. Rapid changes in technology are altering the competitive landscape. Additionally, the manufacturers of LASIK devices are entering and leaving the market more rapidly than manufacturers in more conventional medical fields. n77 The marketplace of laser makers is [*557] rapidly evolving, with some of the makers of today's machines unlikely to be found in existence if cases arise several years hence, and others consolidating and merging assets, perhaps without retaining liabilities for past users of the equipment.

   It may be that the maker of the machine used in a 2001 surgery has disappeared entirely or is not doing business in the United States by 2011, when the LASIK customer learns that his or her serious vision problem was triggered by cellular changes in the aftermath of the surgery. Piercing the corporate veil is a rarity n78 and the device makers will presumably have acted within the law in their merger or dissolution of the corporate structures.

   Likewise, the physician who performs LASIK surgery as the agent of a corporation will seek to be shielded by the corporate form under state corporate laws, as occurred in a Pennsylvania LASIK negligence case. n79 The surgeon may attempt to structure the corporate shell as thinly as possible, so that the corporation or limited liability company can be terminated after a few years or will be insufficiently capitalized to pay judgments that arise from later-detected harms.

   The result of this litany of disappearing defendants is that the eye surgery purchaser of 2003 may be unable to gain compensation in 2013, if and when serious eye problems can be diagnostically attributed to the surgery. The maker of the device is shielded; the surgeon is shielded or the surgeon's corporation is dissolved; and the malpractice carrier is excluded by a claims-made policy format. Clairvoyance is not required to recognize that LASIK's future problems would bring calls for a legislative solution to the absence of compensation or remedy.

   VII. Solutions

   Suggesting a Pooled Reserve Solution

   A certain portion of those who claim a LASIK-induced eye deterioration will correctly attribute their harm to the surgery. Of course, for some injuries there is no compensation because an act of God or force of nature caused the harm: LASIK surgery, however, is the kind of expensive service for which the injured person will expect to be compensated should an unexpected harm occur. The adverse eye [*558] conditions will diminish occupational abilities for persons like airline pilots and will diminish the quality of life for all who depend on clear vision. Such harm would merit some form of compensation under tort law principles if the surgeon acted negligently, if the device the surgeon utilized was negligently designed, or if the plaintiff received inadequate warnings. But, the legal system involves the various limitations noted above, so tort law will deny compensation in most cases.

   Nature abhors a vacuum-and modern media and politics seem to abhor a remediless injured person. Federal compensation for mass injury situations is requested by victims and their advocates in numerous situations. But the actual passage of federal relief legislation is very rare. Agent Orange compensation to military personnel who had served in Vietnam n80 and swine flu vaccine for persons who developed a rare adverse effect are among the rare few. Relief by federal cash assistance to persons who had elective surgery is quite unlikely in this instance.

   The states can respond to future calls for compensation by requiring the insurance carriers who write surgical malpractice coverage to establish a sufficient reserve to be available for future claims. Perhaps in hindsight, such a reserve compensation pool should have been structured for asbestos and other chronic illnesses with belated onset. However, once the medical signs of future problems appeared for those products, the opportunity had passed. The later claims system has borne the higher transaction costs of that inactivity. A state insurance department imposing a surcharge on surgical malpractice policies could create the pool of funding, allowing for claims on the pool in future years to be adjudicated through the tort system, as it operates in the future. Claims for which a viable defendant or carrier exists would be required to be brought first against those viable parties.

   What Loss-Reserve Structure Could Work?

   In light of the probable unavailability of viable defendants for the compensation of longer-term LASIK injuries, as discussed above, this paper advocates the creation of a state-level statutory "risk reserve pool" to pay claims for which no other resources are available. The fund would be used as a limited compensation vehicle with a cap on individual benefits payable upon proof of the elements warranting compensation. Funding for the risk reserve would come from a required surcharge or supplemental coverage payment for the issuance of malpractice insurance covering physicians who perform elective, non- [*559] emergency eye surgery. The payments into the risk reserve pool would be made by the surgeons or their corporate structure, perhaps in the form of a state surcharge of fifty dollars per non-therapeutically indicated n81 eye surgical operation performed. The pool would be held by the state insurance department in escrow as a funding source for any future claims for compensation. If the funds were not the subject of claims for ten years, which seems unlikely given the size of the patient population receiving LASIK surgery, then the fund would dissolve with the surcharges returned to those physicians who "contributed."

   In the event that a LASIK patient's post-operative eye problems are persistent or appear at a point in time set in state legislation, claims would be made against the pool only if normal channels of compensation were foreclosed and only if the surgical event proximately caused the harm to the eye. The long-term negative consequences of these elective eye surgeries might manifest themselves after the plaintiff has found that the conventional routes of compensation, against malpractice coverage of the surgeon or against the device maker, are no longer available. The insurance excise charge would produce the "insurer of last resort" in the state insurance fund.

   Why a State Remedy?

   Since these surgeries are elective purchases of a medical service, n82 they have no federal Medicare cost consequence. These elective sur-geries are not paid for with federal funds, and are not usually provided as an employee benefit, so the federal rules that lead to ERISA pre-emption of state remedies are not likely to inhibit state legislators. At least one court has held that such surgery is not medically necessary but is elective. n83 The state primacy over such surgical activities will be mani-fested by state oversight of malpractice insurance terms and reserves n84 [*560] and by the medical licensure roles of the states. n85 The states that recognize a LASIK compensation issue would be free to employ their authority over insurance carrier policy conditions and loss reserves, as well as the state medical licensing powers over physicians practicing in this area of surgery.

   Of course, how the proposed LASIK injury compensation system will work is yet to be determined. State legislators will first have to hear from a constituency supporting compensation in numbers that can outweigh the power of the medical lobby and the LASIK machine manufacturers' probable defensive alliances. If the experience with HMO legislation in Congress is any indication, many legislators will undoubtedly approach the task of drafting remedial legislation with a pro-patient approach.

   The compromise legislation that ultimately passes may set a standard for recovery from the fund that requires exhaustion of other remedies before a claim can be made to the state fund. Simplified administrative hearings before an administrative agency physician or panel of physicians, attorneys and administrators might be convened. The hearing could be similar to a disability benefits hearing, without the transaction costs of adversarial litigation. Causation of the eye condition will be the major fact issue for the adjudicator or panel, as a delayed effect of damage to the eye could be causally attributed to the LASIK surgery only after close attention to the eye's present condition by an expert ophthalmologist employed as advisor to the panel. The plaintiff's expert would be expected to meet informal norms of qualification, less stringent than the constraints on expert testimony under the Daubert n86 test or other state-law tests of expert witness testimony. Proof of causation could be somewhat relaxed in claims against the fund, perhaps with a set of presumptions concerning the vision deterioration effects of eye surgery and of aging as causal factors, when the legislation establishing the compensation scheme is created.

   The hearing could determine the current amount of eye impairment compared to an age-appropriate eye functions grid, fix the percentage of such current eye condition attributed to the LASIK surgery, and then determine whether another source exists from which benefits would be accessible to the claimant. Payments from the state fund would not be available unless the administrative official in the state department of insurance found sufficient credible evidence from competent medical evaluators that the vision conditions in the patient's eye had been [*561] adversely affected by the results of the elective LASIK eye surgery and that the impairment of vision as of the time of a benefits application was causally attributable to the surgery. Awards could be set up to a maximum amount of compensation, perhaps $ 50,000. If there were a viable civil tort case to be brought, the compensation would not be pursued or might be deferred by the panel.

   Certainly, proponents of the relief legislation will argue for statutory presumptions that eye surgery caused the compensable deterioration while opponents of the statute, including eye surgeons and their malpractice carriers, will argue that the person who bought the elective surgery should be left with the consequences. The degree of relaxation of such proof of causation would likely draw intense debate in the state legislatures. The factual issue of causation based on competing expert testimony regarding the source of the eye deterioration will pose a tough question for the civil jury. If normal aging of the claimant's eye tissue exacerbated the adverse effects of the laser slicing of the eye, the expert will need to opine about relative percentages of causation attributable to the effects of the surgery. The standard of proof in a case involving an older adult with other health problems may be especially difficult for the plaintiff.

   VIII. Conclusion

   New issues suggest new solutions. While laser eye surgery seems today to have few near-term problems, the massive numbers in the target population and the vagaries of human optical problems will pose concerns for trial lawyers. Barriers to recovery, when and if problems are found, will be a challenge to the remedial system of the future. State legislative action and insurance regulatory decisions to establish a risk-pool surcharge may be the optimal means to assure that future claims can be compensated. Plaintiffs' trial counsel will have a role in the creation of this future mechanism for relief, which will entail a focused and intelligent effort for governmental assurance of remedies.

Legal Topics:

For related research and practice materials, see the following legal topics:

TortsMalpractice & Professional LiabilityHealthcare ProvidersHealthcare LawActions Against Healthcare WorkersSurgeonsInsurance LawMalpractice InsuranceClaims Made & Occurrence Policies

FOOTNOTES:

n1 See Diana Digges, $ 4M Award Over Laser-Eye Surgery Breaks New Ground, Law. Wkly. USA, May 27, 2002, at 24.

n2 The author thanks Spectrum Consulting and the media department of the American Academy of Ophthalmology for providing their January 2001 estimates, Spectrum Consulting Associates, 2001 Revised Estimate of the U.S. PRK/LASIK Market & Estimates of PRK/LASIK Breakdown.

n3 In addition to those who purchase LASIK procedures, approximately 165,000 others will purchase photorefractive keratectomy (PRK), another form of eye surgery designed to improve vision. Id.

n4 Oven v. Pascucci, 46 Pa. D. & C.4th 506, 509 n.1 (Pa. Com. Pl. 2000).

n5 A useful reference about LASIK safety is the FDA LASIK, at http://www.fda.gov/cdrh/LASIK/ (last visited Jan. 13, 2003).

n6 Peter Hersh et al., Photorefractive Keratectomy Versus Laser In Situ Keratomileusis, 107 Ophthalmology 925, 931 (May 2000).

n7 Of course, the wording of the advertisements vary with the particular sales approach offered. The emphasis remains on cosmetic appearance benefits, the easier alternatives to glasses, and the affordability of the surgery.

n8 Spectrum Consulting Estimates, supra note 2.

n9 Id.

n10 21 U.S.C. § 321(h) (1999).

n11 Id. § 360E(c) (2000); 21 C.F.R. § 814.20 (2000).

n12 FDA, Checklist of Information Usually Submitted in an Investigational Device Exemption for Refractive Surgical Lasers (Oct. 10, 1996), at http://www.fda.gov/cdrh/ode/2093.html (last visited Sept. 12, 2002).

n13 See FDA-Center for Devices & Radiological Health, Checklist for Filing Decision for PMAs (2001), available at http://www.fda.gov/cdrh/ode/checklist/pma.html (last visited Jan. 13, 2003).

n14 See, e.g. FDA, Center for Devices and Radiological Health Consumer Information: Recently Approved Devices, CDRH Consumer Information Recently Approved Devices at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/mda/mda -list.cfm?list=1 (last visited Sept. 21, 2002).

n15 See FDA, Checklist of Information Usually Submitted in an Investigational Device Exemption for Refractive Surgical Lasers § 3.2.6 (Oct. 10 1996).

n16 FDA, Performance Plan 2002 § 2.6.1 Program Description, Context and Summary of Performance (2002), at http://www.fda.gov/ope/fy03plan/part2 med.html.

n17 FDA, Center for Devices & Radiological Health, LASIK Eye Surgery: What Should I Expect Before, During and After Surgery?, at www.fda.gov/cdrh/lasik/expect.htm (last updated Oct. 1, 2002).

n18 See infra Part V.

n19 Sigma-Tau Pharms. Inc. v Schwetz, 288 F.3d 141, 145 (4th Cir. 2002).

n20 21 U.S.C. § 352(f) (2000).

n21 See Colo. State Bd. of Med. Exam'rs v. Roberts, 42 P.3d 70 (Colo. Ct. App. 2001).

n22 See, e.g., $ 1,750,000 Settlement in Suit Arising from LASIK Eye Surgery, Verdicts, Settlements, & Tactics, July 2002, at 297; Misassembled LASIK Surgery Implement, 45 ATLA L. Rep. 328 (2002).

n23 21 C.F.R. pt. 803.

n24 http://www.fda.gov/medwatch/articles.htm (last visited Jan. 13, 2003).

n25 21 U.S.C. § 360i(b) (2000).

n26 The device user reporting section was partially repealed by Pub. L. No. 105-115, Title II, sec. 213(a)(1)(E), 111 Stat. 2347 (1997).

n27 The rapid increases in volume of LASIK surgeries "adds to the importance of identifying even small risks associated with these elective procedures." David O. Mazur et al., Retinal Detachment in Myopic Eyes After Laser in Situ Keratomileusis, 129 Am. J. Ophthalmology 823, 824 (June 2000).

n28 Restatement (Third) of Products Liability § 2 cmt. a (1997).

n29 A product that is defective and unreasonably dangerous will be addressed with strict liability even if the designer was not negligent. Restatement (Second) of Torts § 402A (1965); see also Restatement (Third) of Products Liability § 2 (1997).

n30 Restatement (Second) of Torts § 402A, cmt. k (1965).

n31 Id.

n32 Restatement (Third) of Products Liability § 6(c) (1997): A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

n33 Id. at cmt. b.

n34 Id.

n35 Minna Vesaluoma et al., Corneal Stromal Changes Induced by Myopic LASIK, 41 Investigative Ophthalmology & Visual Sci. 369, 373 (Feb. 2000).

n36 Id. at 375.

n37 Hersh, supra note 6, at 932.

n38 See, e.g., My LASIK Flap Management Technique, Eye World (Aug. 2002), at http://www.eyeworld .org/aug02/0802p43.html (last visited Sept. 12, 2002).

n39 Jorge L. Alio et al., Selective Zonal Ablations with Excimer Laser for Correction of Irregular Astigmatism Induced by Refractive Surgery, 107 Ophthalmology 662, 670 (April 2000).

n40 Id. at 670.

n41 Yi-Yu Tsai & Jane-Ming Lin, Natural History of Central Islands After Laser In Situ Keratomileusis, 26 J. Cataract & Refractive Surgery 853 (June 2000).

n42 Torben Moller-Pedersen et al., Stromal Wound Healing Explains Refractive Instability and Haza Development After Photorefractive Keratectomy, 107 Ophthalmology 1235, 1236 (July 2000).

n43 Id. at 1243.

n44 Mihai Pop & Yves Payette, Photorefractive Keratectomy Versus Laser in Situ Keratomileusis, 107 Ophthalmology 251, 256 (February 2000).

n45 See Simon P. Holland et al., Avoiding Serious Corneal Complications of Laser Assisted in Situ Keratomileusis and Photorefractive Keratectomy, 107 Ophthalmology 640, 651 (April 2000).

n46 Thomas Clinch, Discussion, commenting on Howard Gimbel et al., Incidence and Management of Intraoperative and Early Postoperative Complications in 1000 Consecutive Laser In Situ Keratomileusis Cases, 105 Ophthalmology 1839, 1847 (Oct. 1998).

n47 See id. at 1847.

n48 Yuichi Hori et al., Medical Treatment of Operative Corneal Perforation Caused by Laser in Situ Keratomileusis, 117 Archives of Ophthalmology 1422 (Oct. 1999).

n49 Posting of letter No One Wins Unless Everyone Wins by Marguerite B. McDonald, Chief Medical Director, Eyeworld, on LasikInfoCenter website (1999) (copy on file with the University of Cincinnati Law Review) ("We are only starting to ride the enormous growth curve of LASIK in this country. There will be more than enough surgeries for everyone to benefit if we keep our heads by sharing information openly and honestly and by resisting the temptation to criticize the work of our colleagues when we are offering a second opinion to a patient with a suboptimal result.").

n50 See Digges, supra note 1, at 24.

n51 Attractive websites offering "safe" surgery include http://www.sightsolutions.com/index-dhtml.htm (last visited Feb. 21, 2003) (no claim is made that this site or others creates an express warranty; it is used for illustrative purposes only).

n52 Conceptually, eye surgery is a service rather than "goods," so the conventional treatment of express warranties under Uniform Commercial Code section 2-313 is available only by analogy.

n53 Laser eye surgery is a source of malpractice claims that have successfully asserted "conscious disregard for the rights and safety" of eye patients. See Siuda v. Howard, No. C- 000656, 2002- Ohio-2292, 2002 WL 946188, at *11 (Ct. App. May 10, 2002). Websites critical of LASIK present more reports of verdicts and settlements. See generally www.lasikdisaster.com (last visited Jan. 2003); http://members.tripod.com/lasik facts (last visited Jan. 2003).

n54 Ellen Dean Smith, New Campaign Aims to Tell the Truth About Laser Surgery, Eye World, at http://www.eyeworld.org/june02/0602p13.html (last visited Jan. 13, 2003).

n55 Daubert v. Merrell Dow Pharms., 509 U.S. 579, 592- 93 (1993). This doctrine is followed in seventeen states. See Joseph Eaton, Survival of the Fryest, 30 Prod. Safety & Liab. Rep. (BNA) 333 (Apr. 15, 2002).

n56 See, e.g., Kubrick v. United States, 444 U.S. 111 (1979) (requiring actions to be initiated within a reasonable time after discovery of the malpractice).

n57 These statutes place procedural restrictions upon the malpractice plaintiff and reduce the potential damage awards.

n58 Colo. State Bd. of Med. Exam'rs v. Roberts, 42 P.3d 70 (Colo. Ct. App. 2001).

n59 A major professional liability insurer explains the distinction: "A 'claims made' policy protects the policyholder against claims or incidents that are reported while the policy is in force, or during an 'extended reporting period.' The negligent act, error or omission must have also occurred during the specific time frame set by the policy." American International Group, Inc., Frequently Asked Questions, at http://www.aigdirect.com/small business/customer service/faq inde x.cfm? PageID=fq020#top (last visited Jan. 13, 2003).

n60 Experts in malpractice coverage estimate ninety percent of malpractice coverage is on a claims-made basis and assume that "in the next five years or so occurrence [policies] will all but disappear." E-mail from Jim Kelley, Coverage, Inc., to James O'Reilly, Visiting Professor of Law, University of Cincinnati College of Law (October 29, 2002 10:43:00 EST) (on file with the University of Cincinnati Law Review).

n61 The statistics are taken from A.M. Best reports and other sources, and were presented to the 2002 Annual Meeting of the American Bar Association by malpractice insurance experts. Theresa W. Bourdon, Address at the 2002 Annual Meeting of the ABA, Tort and Insurance Practice Session (Aug. 10, 2002).

n62 The St. Paul Companies, Inc., News, (Dec. 12, 2001) ("The St. Paul Announces Fourth-Quarter Actions to Improve Profitability and Business Positioning," press release of St. P a u l C o m p a n i e s ) , a t http://www2.stpaul.com/spc/corp/spcnews.nsf/6d54d5b37c9943cc86256 a64006eba96/c007bc65ef 4993c686256b200049e504?OpenDocument (last visited Feb. 21, 2003).

n63 Oven v. Pascucci, 46 Pa. D. & C.4th 506 (Pa. Com. Pl. 2000) (eye laser litigation against corporate provider of the surgical service).

n64 For example, in September 2002, a company called LasikPlus advertised laser vision correction for only $ 299 per eye. Genuine LasikPlus Laser Vision Correction: Now Only $ 299 Per Eye, Cin. Enquirer, Sept. 13, 2002, at D7 (on file with the University of Cincinnati Law Review).

n65 21 U.S.C. § 352(r) (2000) literally covers advertising for "restricted" devices, but in practice the broader class of prescription devices have been within FDA's advertising controls; see also 21 C.F.R. § 801.109.

n66 U.S. Const. art. I, § 8, cl.3.

n67 21 U.S.C. § 321(h) (2000). The LASIK machinery is classified as a medical device under federal regulations. See 21 C.F.R. § 886.4390 (2000).

n68 21 U.S.C. § 360k(a)(1) (1999).

n69 Id.

n70 Id. at § 360k (1999).

n71 See, e.g., Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

n72 Id. (holding that 21 U.S.C. § 360k(a) preempted certain state tort claims).

n73 Pub. L. No. 105-115, 111 Stat. 2296 (1997).

n74 Buckman Co. v. Plaintiff's Legal Comm., 531 U.S. 341 (2001).

n75 See, e.g., Baker v. Medtronic, Inc., No. 2:99- CV- 1355, 2002 WL 485013 (S.D. Ohio Mar. 28, 2002) (holding that preemption precludes virtually all state tort claims against medical device manufacturers).

n76 The issue remains debatable for medical devices like LASIK equipment. Several courts have held that FDA clearance of a label does not preempt state tort cases for failure to adequately warn. See, e.g., Webster v. Pacesetter, Inc., 171 F. Supp. 2d 1 (D.D.C.,2001) (medical device); Eve v. Sandoz Pharms. Corp., No. IP98-1429-C-Y/S, 2002 WL 181972 (S.D. Ind. Jan. 28, 2002) (drug).

n77 Devices for laser eye surgery incur large development costs, making some companies vulnerable, with corporate survival consequences if the equipment does not achieve the desired results. See S.E.C. v. Schiffer, No. 97 Civ. 5853 (RO), 2001 WL 504860 (S.D.N.Y. May 11, 2001); see also In re VISX Sec. Litig., Nos. C-00-0649 CRB, C-00-0815 CM, 2001 WL 210481 (N.D. Cal. Feb. 27, 2001).

n78 This piercing would mean that parent or related corporations and successors might be held liable for injuries alleged to have been the result of a prior dissolved corporation's actions.

n79 Oven v. Pascucci, 46 Pa. D. & C.4th 506, 509 (Pa. Comm. Pl. 2000).

n80 38 U.S.C. § 1116(a)(1) (1991).

n81 A norm such as that used by Medicare for "medically necessary" surgical procedures would separate the aesthetic or convenience self-paid surgeries from those where eye surgery had been performed to respond to a medical need. "Under the Medicare Act, a physician's certification that the ambulance services provided are medically necessary is required before Medicare reimbursement is available." Howard Med., Inc. v Temple Univ. Hosp., No. 00-5977, 2002 WL 169380 at *4 (E.D. Pa. Feb. 1, 2002) (citing 42 U.S.C. § 1395n(a)(2)(2002)). Since this is not provided as an employee benefit, ERISA preemption is not likely to inhibit state responses.

n82 Steven Z. v. Kimberley Z, No. CN00-7918, 2000 WL 1658620 (Del. Fam. Ct. 2000).

n83 Stasack v. Capital Dist. Physicians' Health Plan Inc., 736 N.Y.S.2d 764 (A.D. 3 Dept. 2002).

n84 Federal ERISA recognized the primacy of states in regulating insurance within the states, and these malpractice insurance reserve issues are properly within the realm of state insurance departments. 29 U.S.C. § 1144(b)(2)(A) (1991); UNUM Life Ins. Co. v Ward, 526 U.S. 358 (1999).

n85 See, e.g., Colo. State Bd. of Med. Exam'rs v. Roberts, 42 P.3d 70 (Colo. Ct. App. 2001) (LASIK surgical malpractice led to state medical board disciplinary action).

n86 Daubert v. Merrell Dow Pharms., 509 U.S. 579 (1993).

 
What's OK by the FDA... PDF Print E-mail
This was found in a hearing for CK approval, but it gives you an idea of what's OK by the FDA...

A surgeon can give patients 2 diopters of induced astigmatism as long as it's less than 5% of eyes. That's a LOT of blurry vision folks, and for the record... induced astigmatism was not in my informed consent materials. Was it in yours?

"As shown in this slide, the absolute change in refractive cylinder remained well below the FDA limit of less than 5 percent of eyes with greater than 2 diopters of induced cylinder at all follow-up examinations." P36 lines 6-9.

The below was found at: http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3806t1.rtf
Read more...
 
CANCER & LASER EYE SURGERY PDF Print E-mail

A recent study on the effects of the excimer laser on corneal tissue: Joshua Ben-num (Tzriffin, Israel)

Photorefractive Keractectomy and Laser in situ Keratomileusis: A Word From the Devil's Advocate.

Archives of Ophthalmol. Vol.118, Dec.2000, p.1706-1707.

At a time when there has been a significant improvement in the technology of treatment of refractive errors by laser in-situ keratomileusis (LASIK), this author has issued a very timely warning both to patients undergoing the procedure and to the people performing LASIK.

The procedure involves a laser beam at 193nm that evaporates part of the cornea, breaking cells and molecules to create the smooth corneal surface necessary for best optical results.

The creation of free radicals, is an inseparable part of the cornea reshaping process.

Both photorefractive keratectomy (PRK) and LASIK are known to cause keratocyte apoptosis in the cornea of laboratory animals and hence, though there is no short-term damage, long-term damage must be considered.

These procedures are also known to have caused biochemical and ultrastructural modifications in the lens, both of which are markers of cataractogenesis. The vitreous base, located just posterior to the lens may be affected by the same process that affects the cornea, anterior chamber and the lens. Free radicals damage the vitreous collagen, leading to vitreous liquefaction. They have also been shown to promote tumours.

PRK might initiate a cascade of events leading to slowly developing abnormalities of the cornea, lens, vitreous retina and choroid.

On one hand there is a marked increase in the popularity of LASIK promulgated by massive advertisement. Hence there is an urgent need for intensive research into the potential threats to ocular function caused by LASIK which may occur in patients decades after the initial procedure, slowly but almost surely.

Fatal Focus, a novel by Jonathan Maxx

Read more...
 
Reasons patients recommend LASIK PDF Print E-mail
J Cataract Refract Surg. 2004 Sep;30(9):1861-6.

Bailey MD, Mitchell GL, Dhaliwal DK, Wachler BS, Olson MD, Shovlin JP, Pascucci SE, Zadnik K.

Ohio State University College of Optometry, Columbus, OH 43210, USA.

PURPOSE: To evaluate the reasons patients who have had laser in situ keratomileusis (LASIK) recommend it to others and examine the disparity between high levels of satisfaction and patient reports of night-vision symptoms and/or dry eye after LASIK.

SETTING: Northeastern Eye Institute, Scranton, and the University of Pittsburgh, Pittsburgh, Pennsylvania, and the University of California at Los Angeles, Los Angeles, California, USA.

METHODS: Questionnaires assessing symptoms and satisfaction after LASIK were mailed to 2,100 patients. The questionnaires included items about night-vision symptoms and satisfaction and an open-ended question for patients to give their reasons for recommending LASIK to others. The open-ended responses were categorized and tabulated.

RESULTS: Four hundred thirty-four patients provided reasons for recommending LASIK to others. Sixteen categories of reasons were identified. "No more spectacles/contact lenses" was listed by 180 patients (42%), followed by "better vision" (21%) and "convenience" (15%). Women were significantly more likely to cite "better comfort" (27 women versus 3 men; chi square = 8.99, P =.003) and "better quality of life" (41 women versus 9 men; chi square = 7.36, P =.007) as a reason for recommending LASIK. Of the 35 patients who reported dissatisfaction with post-LASIK vision, 20 (57%) would recommend LASIK to a friend because "LASIK helps others."

CONCLUSIONS: Categories of reasons for recommending LASIK to others were similar to reasons given by patients for seeking LASIK. Some patients who reported dissatisfaction with their vision said they would recommend LASIK, suggesting that recommendation of LASIK to others is not necessarily a measurement of the quality of a patient's vision after LASIK.

 
Dangers of Suction Ring and Laser Acoustic Shock PDF Print E-mail
JRS September/October 2005 21:5 p502.
Lin and Tsai.
Retinal Plebitis After LASIK

Excerpt:

"An IOP of at least 65mmHg is necessary to create a corneal flap with the microkeratome. During this time, the shape of the anterior segment may change rapidly and structures posterior to the suction ring are also compressed in sequence. When the suction stops and the suction ring is released, ocular decompression leads to dynamic equatorial elongation and anterior-posterior contraction. This barotrauma is analagous to what happens in closed eye injury, and can alter delicate retinal structures, especially small vessels, and induce vitreoretinal traction at the vitreous base and posterior pole. Sudden elevation of IOP also disturbs the retinal circulation and increases venous pressure, which results in retinal ischemia. All of these conditions may aggravate the original impaired blood-retinal barrier in highly myopic eyes and increase vascular permeability, leading to the loss of integrity of tight junctions of endothelial cells. Laser in-situ keratomilieusis-induced shock waves can generate up to 100atm. Although the pressure decreases steadily to values below 10 bars toward the retina, we believe it may still cause mechanical stress to the retina, resulting in structural damage and intraocular inflammation.
In addition, total energy and duration increase with higher refractive error and the effect of mechanical stress may be more severe in higher myopia, which has more liquification of the posterior vitrous gel."
 
Quotes, Non Peer-Reviewed Articles, and More PDF Print E-mail

Informed Consent

"What concerns me is that if the person informing the patient is themselves poorly or inaccurately informed then how on earth can consent ever be truly informed?" Dr. Sarah Smith.

AND MORE...

Cleaner LASIK: Is it Possible?

SOURCE

This from a doctor who was fined $1.1 Million from the FDA for damaging 125 patients...

Fixing a lost or slipped flap

SOURCE

EyeWorld

November 2006

Quote:

“Lost flaps usually will occur in the operating room where the microkeratome just made too superficial a cut,” Dr. Geggel said. “Surgeons have to be comfortable knowing how to take the microkeratome apart, because the lost flap is usually going to be somewhere within the machine.”  

"Make sure the first patient you enroll feels like you have been doing this for years..."

SOURCE

Stephen S. Lane, M.D.:

EyeWorld

October, 2005

IOL calculations after refractive surgery need extra care

SOURCE

Excerpt:  The topic of  IOL implantation after refractive surgery and power calculations arose a few years ago. However, Dr. O'Brien noted that now this situation is arising on a daily basis in practices as the number of refractive procedures increases each year and as the population ages.  "There has been a question of whether laser refractive surgery is accelerating the development of cataract. This is controversial, but I see it more and more often in my practice," he said. Dr. O'Brien is professor of ophthalmology and director of the Refractive Surgery Service, Bascom Palmer Eye Institute, Miami.  The problem, he pointed out, is that the patients who have undergone refractive surgery and then develop cataract are different in mindset from the traditional patient with cataract in that they have extraordinarily high expectations; they want immediate results; and they want no surgical discomfort, sutures, or downtime after the procedure.

"These patients who develop cataract after refractive surgery want a perfect outcome. They are potentially frustrated and angry because their quality of vision has suffered as the result of the refractive surgery, and the results may be unpredictable. Interestingly, incorrect power is the most common reason for IOL explantation. This is the result of our not being able to determine the power as accurately as we would like," he stated and advised exercising extra care with these patients.

"Successful LASIK" is an oxymoron

Found on Lasik-Flap bulletin board: http://www.lasik-flap.com/forum

The flap never heals. It cannot heal. All it can do is form a scar at the margin of the flap which is only 28% as strong as a normal cornea. The flap itself does not bond to the underlying cornea and can be dislodged or lifted years later.

The corneal nerves that play a vital role in tear production never fully regenerate. A scientific peer-reviewed study proved that at 3 years post-op the corneal nerves are still less than 60% of pre-op densities. LASIK induced dry eyes is common and for many patients is a life-long sentence.

The suction ring used during the cutting of the flap damages the delicate structures inside the eye including the retina, vitreous, and optic nerve. Many patients report increased floaters (posterior vitreous detachment) after LASIK, and some experience retinal tears or detachment, lacquer cracks, macular holes, macular hemorrhages, optic neuropathy, and retinal vein occlusion.

LASIK corneas are not as stable as normal corneas and can begin to bulge weeks, months, or even years later, potentially resulting in loss of the cornea. This bulging is a response to the normal intraocular pressure. A LASIK-weakened cornea sometimes can no longer withstand this outward force. The FDA used a best-guess safety limit of 250 microns of cornea under the flap when LASIK was approved. Since then it has been shown in the medical literature that 250 is not a safe limit, even though the vast majority of LASIK surgeons, who are too busy doing LASIK to follow the research, are still using an unsafe limit of 250 microns. And the FDA does not have the backbone to modify the approval, allowing the LASIK industry to continue this unsafe practice that jeopardizes the well-being of millions of patients.

There is permanent damage in 100% of LASIK corneas -- debris in the space between the flap and the underlying cornea, undulations and microfolds in the Bowman's layer -- presumably because the flap doesn't fit to the altered corneal bed, haze, epithelial cells under the flap, acutely and chronically reduced keratocytes, epithelial thickening, collagen fibril disorganization, collagen lamellar disarray, and abnormalities of the Descemet membrane.

Quote from one peer-reviewed study: "However, the presence of pathologic findings up to 7 years after LASIK indicates that the process of corneal stroma wound healing never completely regenerates histopathologically normal corneal stroma."

Loss of night vision quality after LASIK occurs frequently, according to a 2002 report by the American Academy of Ophthalmology. For some patients, particularly those with large pupils, this complication can be debilitating. Since this is a "frequent" problem after LASIK, I wonder how many of the approximately 8 million Americans who have had LASIK are out there on the roads at night endangering their life and the lives of others who share the roads with them? A recent study showed that up to 50% of LASIK patients are impaired when driving at night. Yet this serious threat to the public health is down-played and swept under the rug by the LASIK industry.

And then we have the problem of the white wall of silence. Doctors are pressured by their peers not to testify for patients who are victims of LASIK malpractice. They are threatened by their own insurance carriers, which could put them out of business. And they are concerned about giving LASIK a black eye by helping a patient seek justice for the harm done to him or her in a public forum like a court of law. They cave in to the pressures, leaving patients without any recourse -- medical, legal or otherwise. So doctors just get away with it and standard of care and informed consent continue to be basically non-existent. And the FDA says it's not their problem (they regulate the devices, not the doctors).

So who's looking out for the patients? Who's going to warn them that 1/3 of their corneas will be nearly sliced off, leaving them with a structurally weakened cornea that can begin to bulge years down the road? Who's going to warn them of the seriousness of LASIK-induced dry eyes, that the nerves never regenerate, and that painful dry eyes can be permanent? Who's going to warn them that LASIK, all LASIK -- conventional and custom, induces higher order aberrations in all virgin corneas, effectively reducing the quality of their vision? Who's going to warn them of the damage the suction ring can do to the structures inside the eye? Who's going to warn them that the flap never heals?

You would think doctors would be protecting patients. Wake up and smell the coffee. Money is what drives them, not a desire to heal the sick. They don't deserve to be called doctors. They are no better than used car salesmen.

American Academy of Ophthalmology. For some patients, particularly those with large pupils, this complication can be debilitating. Since this is a "frequent" problem after LASIK, I wonder how many of the approximately 8 million Americans who have had LASIK are out there on the roads at night endangering their life and the lives of others who share the roads with them? A recent study showed that up to 50% of LASIK patients are impaired when driving at night. Yet this serious threat to the public health is down-played and swept under the rug by the LASIK industry.

Mistakes / Errors

JOURNAL OF REFRACTIVE SURGERY
Vol. 22 No. 3 March 2006  
Dan Z. Reinstein, MD, MA(Cantab), FRCSC; Cynthia Roberts, PhD  

Excerpt:  "Some of the evidence pointing to the impact of corneal biomechanical properties on surgical outcomes lies in the measurement of intraocular pressure (IOP), both before and after refractive surgery. It is well known that measured IOP is reduced, on average, following a refractive procedure. It has been assumed that this is the result of reduced curvature and thickness in myopic procedures. However, Chang and Stulting performed a retrospective review of over 8000 myopic LASIK patients, and determined that although measured pressure was reduced on average by approximately 2 mmHg, the range of change was approximately +10 to -15 mmHg. Every patient in this population had reduced thickness and curvature, and yet almost half of them had an increase in measured IOP.  

Clearly, the artifact in IOP measurement cannot be explained by thickness alone, and “correction” of measured IOP postoperatively using a linear correction factor based on thickness is problematic. This leads to the conclusion that refractive surgery likely alters the fundamental biomechanical properties of the cornea.

Lasers or Surgeons: What's really the cause of high retreatment rates?

SOURCE

EyeWorld
January 2005

“I had one time where I had to put the flap back with a flashlight because the illumination light went off so I couldn’t figure out where the flap was,” Dr. Rubinfeld said.

Interface fluid after LASIK

J Cataract Refract Surg. 2001 Sep;27(9):1526-8.

Fogla R, Rao SK, Padmanabhan P.  Cornea Services, Sankara Nethralaya, Chennai 600 006, Tamil, Nadu, India. mrf@sankaranethralaya.org  

We report a case in which raised intraocular pressure (IOP) was associated with interface fluid after uneventful bilateral laser in situ keratomileusis (LASIK). The patient presented with diffuse lamellar keratitis in both eyes 3 weeks postoperatively that was treated aggressively with topical corticosteroids. A steroid-induced rise in IOP resulted in interface fluid accumulation and microcystic edema. Measurements with the Goldmann tonometer revealed an IOP of 3.0 mm Hg in both eyes. However, Schiotz tonometry recorded a pressure of 54.7 mm Hg in both eyes. Reduction in the dosage of topical corticosteroid and medical treatment of the raised IOP resulted in resolution of the microcystic edema and interface fluid accumulation. This case highlights the inaccuracies of IOP measurement after LASIK and the resulting complications.

LASIK: three unexpected complications

J Refract Surg. 2001 Mar-Apr;17(2 Suppl):S177-9.  Rosa DA.

PURPOSE: To report unexpected outcomes in three patients after uneventful laser in situ keratomileusis (LASIK) performed using the Nidek EC-5000 excimer laser and the Hansatome microkeratome (Bausch & Lomb Surgical).

METHODS: LASIK was performed with the Nidek EC-5000 excimer laser and the Hansatome microkeratome (Bausch & Lomb Surgical) in three patients.

RESULTS: In three patients, unexpected outcomes were observed. One patient treated for -3.00 D of myopia presented with a central island. One patient treated for +2.00 D (+1.00 x 90 degrees) of hyperopia in both eyes ended up emmetropic in one eye and overcorrected in the fellow eye. The third patient with -12.00 D (-2.00 x 180 degrees) of myopia was treated as -8.60 -1.00 x 180 degrees and at last examination was +4.00 D. During these sessions, all other patients treated were within +/-0.50 D of emmetropia.

CONCLUSION: After LASIK with the Nidek EC-5000 excimer laser and the Hansatome microkeratome (Bausch & Lomb Surgical), unexpected outcomes may still occur, despite controlling all the usual variables.

Oculocardiac reflex in a nonsedated LASIK patient

J Cataract Refract Surg. 2002 Sep;28(9):1698-9.  

Baykara M, Dogru M, Ozmen AT, Ozcetin H.  Uludag University Faculty of Medicine, Department of Ophthalmology, Bursa, Turkey 

A healthy 21-year-old man had laser in situ keratomileusis (LASIK) in the right eye for a refractive error of -7.0 diopters. The electrocardiogram findings and heart rate were recorded before LASIK; during eye lid speculum insertion, vacuum application, corneal flap preparation, and excimer laser keratectomy; and after the procedure.

The pre-LASIK heart rate was 90 pulses/min. Severe bradycardia of 40 beats/min developed during vacuum application, and the procedure was terminated. Severe bradycardia caused by an oculocardiac reflex may occur during LASIK, and patients should be closely monitored during the procedure.

LASIK complication: loss of electricity to the microkeratome during the forward pass

Acta Ophthalmol Scand. 2003 Oct;81(5):530-2.  

Tuominen IS, Tervo TM.  Department of Ophthalmology, Helsinki University Hospital, PO Box 220, HUS, SF-00029 Helsinki, Finland. ilpo.tuominen@hus.fi  

CONTEXT: A 32-year-old woman was scheduled for myopic laser in situ keratomileusis (LASIK) because of myopia and anisometropia caused by retinal detachment surgery.  

CASE REPORT: During surgery, a sudden malfunction of the microkeratome during the forward pass was experienced. It was not possible to reverse the blade manually along the suction ring. Moreover, disconnecting the suction from the control unit did not help at first, because the suction ring was firmly attached to the ocular surface. However, detaching the suction line from the control unit aborted the vacuum and allowed the surgeon to turn the whole microkeratome backwards, mimicking the normal blade movement. Finally, an almost normal flap was observed, and the operation was successfully completed. Afterwards, the wire to the electromotor of the microkeratome was found to be broken and subsequently replaced.  

CONCLUSION: This type of unforeseen microkeratome malfunction may result in serious flap or other complications.

Refractive surprise after LASIK

Arch Soc Esp Oftalmol. 2005 Sep;80(9):547-9. Related Articles, Links

CASE REPORT: A female patient underwent laser in situ keratomileusis (LASIK) in both eyes. The final degree of astigmatism in her left eye was double the preoperative value due to an error in data management. Complex surgery to both eyes was necessary to resolve the mistake.

DISCUSSION: Complications in refractive surgery can occur, however errors in data management must be minimized by double-checking. Solutions to resolve the errors made can be difficult and the entire staff must share responsibility to avoid these undesirable outcomes.

Failure to verify treatment parameters can lead to LASIK errors

SOURCE

TOP STORIES 3/24/2006  

Quote: In the last case, the patient allowed the surgeon to call him “José” several times, believing the surgeon was making a joke. Only after one eye had been treated incorrectly did he clarify his name was “Carlos,” Dr. Sonal said.

Turn Around These LASIK Letdowns

Review of Optometry  

Excerpt:  For most carefully chosen patients, LASIK continues to improve their quality of life significantly. However, the popular media that once portrayed LASIK as a somewhat miraculous procedure now tell horror stories of people visually disabled by LASIK gone awry.  

Read the entire article at:

http://www.revoptom.com/index.asp?ArticleType=SiteSpec&page=osc/oct01/lesson_1001.htm

What's Next for LASIK?

Ophthalmology Management Issue:
September 2004  

Outcomes are better than ever, but its place as the dominant refractive procedure is now in doubt.  By Jerry Helzner 

http://www.ophmanagement.com/article.aspx?article=86168

These additional studies (all PDF documents) also interesting to read:

Adhesion abnormalities associated with LASIK  Intralase causes macular hemorrhage RGP discontinuation before LASIK
Artificial cornea transplant  Intralase vs microkeratomes Severe central epithelial defects
Contrast sensitivity function  LASIK causes glaucoma Thick and thin LASIK flaps
Cornea donation  Measuring cornea thickness Visx - Measuring Pupil Size Preoperatively
Corneal reinnervation after lasik  Microkeratome assessment Visx Requirement of Patient Information Booklet 
Donnenfeld flap experiment  Microkeratome evaluation 1  
Ectasia after LASIK  Microkeratome evaluation 2  
Environmental factors myopic LASIK  Microkeratome evaluation 3  
Epithelial adhesion abnormalities  Microkeratome evaluation 4  
Flap complications aborted surgery Night vision complaints 1  
Flap tear during enhancement  Night vision complaints 2  
Gayton rejects LASIK  Night vision complaints 3  
Humidity temperature risks  Non-surgical eyewash problems  
Infections following LASIK Peripheral relaxing incisions after LASIK  
Informed consent doctor tool Pupil size night vision  
 
Comparative results of keratometry with three different keratometers after LASIK PDF Print E-mail

SOURCE

Klin Monatsbl Augenheilkd. 2005 May;222(5):419-23.

[Article in German]

Schafer S, Kurzinger G, Spraul CW, Kampmeier J.

Augenklinik, Universitatsklinikum Ulm.

BACKGROUND: Postoperative hyperopia is a frequent result of cataract surgery in eyes after previous myopic kerato-refractive surgery. One reason for the underestimation of intraocular lens (IOL) power is the wrong corneal refractive power measurement obtained by keratometers and corneal topography systems after LASIK. The aim of this study was to compare the precision of measurements of three different keratometers after LASIK.

METHOD: We studied 58 eyes of 34 refractive patients aged between 20 and 51 years. The preoperative measurements and the measurements one month after LASIK were performed with the Keratometer (Zeiss), the corneal topograph (EyeSys Technologies) and the IOL-Master (Zeiss). We compared our postoperative measurement results obtained with the three keratometers with the results obtained by using the clinical history method (chm).

RESULTS: The smallest mean deviation was achieved with the IOL-Master (measured mean +/- SD: 38.94 +/- 1.88 D, vs. chm: 38.35 +/- 2.13 D). The Keratometer (Zeiss) showed a larger deviation (measured: 39.12 +/- 1.76 D, chm 38.34 +/- 2.07 D) and the largest deviation was shown with the corneal topograph (measured: 39.84 +/- 1.85 D, chm: 38.86 +/- 2.10 D), which measured in mean one diopter higher than what was obtained utilizing the chm. A positive correlation between corrected myopia and the postoperative difference between the measured and calculated value for each keratometer was found.

CONCLUSION: This study demonstrates that with common keratometers central corneal power is measured too high after LASIK. For IOL calculation in patients after LASIK, the wrongly positive deviation from measured central corneal power has to be taken into account.

 
Mitomycin C (MMC) Studies & Articles PDF Print E-mail

Dry eye after PRK with adjuvant mitomycin C

J Refract Surg. 2006 May;22(5):511-3.

Kymionis GD, Tsiklis NS, Ginis H, Diakonis VF, Pallikaris I.

Department of Ophthalmology, Institute of Vision and Optics, University of Crete, Heraklion, Greece. kymionis@med.uoc.gr

PURPOSE: To report a patient with dry eye after bilateral photorefractive keratectomy (PRK) with mitomycin C treatment in one eye.

METHODS: A 29-year-old woman underwent PRK for moderate myopia. The left eye was randomly assigned and intraoperative topical mitomycin C was administered. The right (control) eye was treated with intraoperative corticosteroid only.

RESULTS: The patient developed dry eye symptoms and superficial punctuate keratopathy in the eye treated with mitomycin C. Fifteen months after surgery no improvement was noted.

CONCLUSIONS: Photorefractive keratectomy with mitomycin C treatment could induce or exacerbate dry eye.

Mitomycin C in the Aqueous Following Corneal Application

http://www.aao.org/education/sit_cornea/0019.cfm

Specialty News and Views: Cornea/External Disease - April 2006

The Specialty News and Views section represents the opinions of the contributing authors and does not imply endorsement by the American Academy of Ophthalmology. The Cornea/External Disease team members are: Donald Stone, MD; Surendra Basti, MD; Thomas Harvey, MD; Saiyid Hasan MD; and Ivan Schwab, MD.

A recent animal study showed that mitomycin C (MMC) was consistently detected in the aqueous following a 2 minute application of the solution to corneas with and without an intact epithelium.1 The primary intent of Torres and colleagues was to study eyes where MMC had been applied following photorefractive keratectomy (PRK).

After applying MMC 0.02% for 2 minutes to 2 groups of hen eyes—those that had PRK and those with intact corneal epithelia—the researchers sampled aqueous humor at different time points (10, 30, 60, 360, and 720 minutes). High performance liquid chromatography detected significant quantities of MMC in both groups up to 60 minutes after application. Eyes with PRK had higher levels and could be seen up to 360 minutes later. No drug was undetectable in any eye at 12 hours.

While the presence of MMC in the aqueous following application during glaucoma filtration procedures has been documented, there has been a paucity of literature regarding aqueous levels in eyes following application to the ocular surface. This study unequivocally demonstrates that MMC remains in the aqueous in all eyes following topical application.

MMC is a potent wound healing modulator used by glaucoma, refractive, and corneal surgeons. Advocates of its use have extrapolated success of this agent in decreasing failure of filtration blebs to areas of refractive and corneal surgery. Its efficacy has led to a progressive widening of its applications in recent years. However, this antineoplastic agent can have potential long-term consequences on intraocular structures, because it blocks DNA-RNA replication and protein synthesis.

Previous studies involving topical application of MMC 0.04% at 3-4 times a day have demonstrated ocular surface toxicity on impression cytology and suggested a radiomimetic effect for at least 8 months following therapy.2,3 It is also believed that the toxic effects of MMC can be delayed and cumulative. In light of these facts, it is evident that more investigations of the pharmacokinetic and cytotoxic effects of MMC are needed, particularly with regard to aqueous levels. In the interim, it may be prudent to limit the use of this agent as well as to provide informed consent about the lack of knowledge regarding the long-term effects of MMC.

REFERENCES:

1. Torres RM, Merayo-Lloves J, Daya SM, et al. Presence of Mitomycin-C in the Anterior Chamber After Photorefractive Keratectomy. J Cataract Refract Surg. 2006;32: 67-71.

2. McKelvie PA, Daniell M. Impression cytology following mitomycin C therapy for ocular surface squamous neoplasia. Br J Ophthalmol. 2001;85:1115-1119.

3. Dogru M, Erturk H, Shimazaki J, Tsubota K, Gul M. Tear function and ocular surface changes with topical mitomycin (MMC) treatment for primary corneal intraepithelial neoplasia. Cornea. 2003;22:622-639.

Presence of mitomycin-C in the anterior chamber after PRK

J Cataract Refract Surg. 2006 Jan;32(1):67-71.

Torres RM, Merayo-Lloves J, Daya SM, Blanco-Mezquita JT, Espinosa M, Nozal MJ, Bernal JL, Bernal J.

Instituto Universitario de Oftalmobiologia Aplicada, Universidad de Valladolid, Spain.

PURPOSE: To assess the presence of mitomycin-C (MMC) in hen aqueous humor after photorefractive keratectomy (PRK).

SETTING: Instituto Universitario de Oftalmobiologia Aplicada, Faculty of Medicine, University of Valladolid, and Department of Analytical Chemistry, Faculty of Sciences, University of Valladolid, Valladolid, Spain.

METHODS: Mitomycin-C 0.02% was applied topically for 2 minutes to a right hen's eye after PRK (Group A) and to the left eye with intact epithelium (Group B). At different time points (10, 30, 60, 360, and 720 minutes), aqueous humor was extracted and high-performance liquid chromatography was performed to detect and quantify MMC levels.

RESULTS: The mean maximum drug concentration of MMC measured in the aqueous humor was 187.250 microg/L +/- 4.349 (SD) in Group A and 93.000 +/- 4.899 microg/L in Group B, both detected 10 minutes after topical application. Statistically significant differences were found between Groups A and B at 10, 30, and 60 minutes, with decreasing MMC levels in both groups but a higher concentration in Group A. After 360 minutes, MMC levels were undetectable in Group B and after 720 minutes in Group A.

CONCLUSIONS: Mitomycin-C was detectable in the aqueous humor of the hen eye after topical application in PRK-treated eyes and in eyes with intact epithelium. The presence of MMC is of concern as it may lead to ocular toxicity in the long term.

Impression cytology following mitomycin C therapy for ocular surface squamous neoplasia

Br J Ophthalmol. 2001 Sep;85(9):1115-9.

McKelvie PA, Daniell M.

Department of Anatomical Pathology, St Vincent's Hospital, Melbourne, Victoria, Australia.
mcelevpa@svhm.org.au


BACKGROUND/AIMS: Topical mitomycin C (MMC) therapy has been used for treatment of ocular surface squamous neoplasia (OSSN) since 1994. Relatively few studies have reported the cellular changes in ocular surface following MMC.

METHODS: Impression cytology was studied in four patients with ocular surface squamous neoplasia, either primary or recurrence after previous excisional biopsy. The authors studied samples obtained using Millipore filters at intervals between 4 and 17 weeks after commencement of MMC, and compared them with pretreatment cytology.

RESULTS: MMC induced changes of cytomegaly, cytoplasmic vacuolation, nucleomegaly with nuclear wrinkling, and binucleation or multinucleation were seen in some cells in all samples. However, nuclear/cytoplasmic (N/C) ratio in these enlarged cells was normal. These changes mimicked those seen following radiation therapy in uterine cervix. Changes of increased nuclear and cell size with increased N/C ratio were seen in some dysplastic cells. The predominant form of cell death was apoptosis with fewer cells showing necrosis.

CONCLUSIONS: MMC appears to produce cell death in OSSN by apoptosis and necrosis. Cellular changes related to MMC mimic those caused by radiation-cytomegaly, nucleomegaly, and vacuolation. MMC related changes may persist in ocular surface epithelium for at least 8 months following MMC therapy.

Tear function and ocular surface changes with topical mitomycin (MMC) treatment for primary corneal intraepithelial neoplasia

Cornea. 2003 Oct;22(7):627-39.

Dogru M, Erturk H, Shimazaki J, Tsubota K, Gul M.

Uludag University, Faculty of Medicine, Department of Ophthalmology, Bursa, Turkey.
muratodooru@yahoo.com


PURPOSE: To evaluate the tear function and ocular surface alterations in patients with primary CIN before and after treatment with topical mitomycin (MMC).

PATIENTS AND METHODS: We describe seven patients with unilateral CIN treated with 0.04% topical MMC three times daily until full eradication of the lesion. The patients underwent tear and ocular surface examinations including Cochet-Bonnet corneal sensitivity measurements, tear film break-up time (BUT), Schirmer test, and Rose-Bengal staining before, at the time of resolution of the CIN, and at the final follow-up. Conjunctival impression cytology was performed before treatment and at the last visit.

RESULTS: The mean pretreatment corneal sensitivity was 30.3 +/- 7.4 mm and improved to 55 +/- 5 mm at the final visit (P < 0.05). There were no aqueous-deficient eyes. The BUT values and Rose-Bengal staining scores also showed significant improvement at the last follow-up compared with the pretreatment values (P < 0.05). Initial impression cytology specimens showed goblet cell loss, higher grades of squamous metaplasia, areas of isolated keratinized, binucleated, and actively mitotic disfigured epithelial cells in all patients. The mean goblet cell density and squamous metaplasia grade were observed to improve significantly at the last visit (P < 0.05). MMC-induced cytologic changes were seen to persist long after cessation of treatment in some patients. All eyes remained free of recurrence and complications during the follow-up period.

CONCLUSION: We found 0.04% topical MMC treatment tid until full eradication to be effective in the management of CIN. The ocular surface disease of CIN was characterized by disturbance of tear film stability, goblet cell loss, and increased squamous metaplasia in all patients. Impression cytology proved useful in attaining the diagnosis of CIN, evaluating the effect of treatment, and showing MMC-related long-term changes on the ocular surface.

Early corneal edema following topical application of mitomycin-C

J Cataract Refract Surg. 2004 Aug;30(8):1742-50.

Chang SW.

Department of Ophthalmology, Far Eastern Memorial Hospital, 21 ZSection 2, Nan-Ya South Road, Ban-Chiao, Taipei 220, Taiwan.
swchang@mail.femh.org.tw


PURPOSE: To determine the effect of mitomycin-C (MMC) on the cornea after a single intraoperative application.

SETTING: Department of Ophthalmology, Far Eastern Memorial Hospital, Ban-Chiao, Taipei, Taiwan.

METHODS: Mechanical epithelium debridement of the central 10.0 mm of the cornea was performed in 63 pigmented rabbits. One group of corneas (MMC1, n = 42) was soaked with MMC 0.01% solution for 2 minutes; the second group (MMC2, n = 42) was soaked with MMC 0.02% solution for 2 minutes. Control corneas (n = 42) were soaked with balanced salt solution for 2 minutes. Changes in the central corneal thickness, clarity, epithelial defect size, endothelial cell density, and endothelial apoptosis in the 3 groups were examined on days 0, 1, 2, 3, 5, 7, and 14.

RESULTS: There was a dose-dependent increase in corneal thickness, decrease in corneal clarity, and increase in endothelial apoptosis after a single intraoperative application of MMC. The endothelium was significantly swollen and became pleomorphic and polymegethic with a concomitant decrease in endothelial cell density, also in a dose-dependent manner.

CONCLUSIONS: A single application of MMC on the corneal surface caused dose-dependent corneal edema and endothelial apoptosis in the rabbit model. Further clinical study of human eyes is warranted.

Intraoperative mitomycin C and the corneal endothelium

Acta Ophthalmol Scand. 1998 Feb;76(1):80-2.

Sihota R, Sharma T, Agarwal HC.

Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi.

PURPOSE: Mitomycin-C (MMC) is a useful adjunct to high risk glaucoma surgery. No clinical data regarding the deleterious effect of mitomycin-C on the corneal endothelial cells are available.

METHODS: Thirty eyes of 28 adult patients with high risk glaucomas were randomized to three groups. Group-I underwent a trabeculectomy alone, Group II, trabeculectomy with intraoperative 0.2mg/ml MMC and Group III, trabeculectomy with intraoperative 0.4mg/ml MMC. Preoperative and 3-month postoperative corneal endothelial cell counts were analysed.

RESULTS: The percentage cell loss in Group I was 3.73+/-2.73%, in Group II 13.90+/-4.69% and in Group III 14.52+/-7.8%. Statistical analysis revealed a significant difference in cell loss between Group I and Group II and Group I and Group III, but not between Group II and Group III.

CONCLUSION: There is a significant loss of corneal endothelial cells three months after trabeculectomy with adjunctive MMC.

Non-peer reviewed:


http://www.ophthalmologytimes.com/ophthalmologytimes/article/articleDetail.jsp?id=405941


R. Doyle Stulting MD:

"Ectasia is estimated to occur in one of every 2,500 patients undergoing LASIK, Dr. Stulting said, "but this may be an overestimate because of current exclusion criteria. It also may be an underestimate because of limited follow-up."

Reported cases of ectasia have been diagnosed up to 4 years after LASIK, he added, also noting a case of ectasia that required corneal transplantation 13 years after PRK.

"Pathology in this case suggests cell loss and abnormalities of keratocytes, leading us to wonder whether defective keratocyte metabolism could make ectasia more likely and to wonder whether mitomycin C might increase the long-term risk of ectasia," Dr. Stulting said."

Corneal keratocyte deficits after photorefractive keratectomy and LASIK

Am J Ophthalmol. 2006 May;141(5):799-809.

DR STEVEN E. WILSON:

Quote:

I encourage you to use the same technology to look at patients who are having mitomycin prophylactic treatment for prevention of haze; probably 90 percent of refractive surgeons are using mitomycin without any long-term data as to the effect. It is clear the reason mitomycin works so well is that it eliminates 100 percent of all corneal cells in about 20 percent of the anterior cornea. Similar to your concerns, I think they are even magnified in those patients because data after six months in the animal model shows that none of those cells have returned. What happens in the future since we have limited experience with these types of patients? In 10 to 20 years, are we going to see anterior corneal necrosis or other problems? Your type of study could give us more data about that in humans.

This one is not peer-reviewed:

Mitomycin-C can reduce corneal haze after laser refractive surgery

http://www.osnsupersite.com/view.asp?rID=20313


OCULAR SURGERY NEWS U.S. EDITION February 1, 2007

Francesco Carones, MD, explains how MMC can be used to treat or prevent haze.

By Francesco Carones, MD

Quote:

The major criticism in the use of MMC after laser refractive surgery refers to the potential side effects and complications associated with its long-term cytostatic action on tissues when applied in a topical fashion on the corneal stroma. Several researchers have reported corneoscleral melt after MMC application after pterygium excision. Also, the long-term integrity of the endothelial layer is supposed to be at risk.

LASEK, epi-LASIK to remain niche procedures despite some advantages, surgeon says

http://www.osnsupersite.com/view.asp?rID=26511
OSN SuperSite Breaking News 2/20/2008

Excerpt:

Quote:

"This is, in my opinion, the only potential benefit of these procedures: They minimize the risk of haze without the use of mitomycin-C, which is not such an innocent drug," she said.

She strongly emphasized that the
use of mitomycin-C by refractive surgeons should strictly be limited to high-risk eyes. Cases of scleral melting were found, in her personal experience, 3 to 4 years after using the drug
in pterygium surgery, and the need for dilution poses further problems.

 

Endothelial Decompensation Following Epithelial LASIK With Loss of Epithelial Flap

Journal of Refractive Surgery Vol. 25 No. 1 January 2009
Sameer Kaushal, MD; Gaurav Prakash, MD; Namrata Sharma, MD; Jeewan S. Titiyal, MD

Quote:

Apart from excimer laser or suction ring, other potential factors include postoperative medications. Pfister has reported a case of endothelial decompensation due to the use of topical mitomycin C eye drops for the treatment of corneal haze. He postulated that the absence of the epithelial barrier allowed significant penetration of the drug into the anterior chamber, damaging the corneal endothelial cells.

-

Quote:

Mitomycin C treatment after PRK or other surface ablation procedures has been used empirically for years to block haze formation.14 Recently, animal studies have been performed to determine the mechanisms through which mitomycin C blocks the haze response. Although mitomycin C augments the normal apoptosis response that occurs after epithelial scrape performed during PRK,15,16 Netto et al16 demonstrated that the most notable effect is in the inhibition of mitosis of cells that function to repopulate the anterior stroma (Fig 7). Thus, progenitor cells to myofibroblasts, in addition to keratocytes, are blocked from proliferating. The end result of this treatment is that the anterior stroma has profoundly diminished cell density lasting for more than 6 months after mitomycin C treatment.16 It has not been determined when, if ever, more normal keratocyte density is restored in the anterior stroma after mitomycin C treatment. Because keratocytes function to maintain collagen, glycosaminoglycans, and other matrix materials in the stroma, there is concern regarding the long-term effects of mitomycin C, possibly measured in decades, on corneal morphology and function.16



Marcella Q. Salomao, MD and Steven E. Wilson, MD. Corneal Molecular and Cellular Biology Update for the Refractive Surgeon. J Refract Surg. 2009 May

One-year outcomes of a bilateral randomised prospective clinical trial comparing PRK with mitomycin C and LASIK

A D Wallau and M Campos

Br J Ophthalmol 2009 93: 1634-1638 originally published online November 4, 2009

Quote:

The concern for mitomycin C use stems from complications arising in scleral and corneoscleral procedures with mitomycin C, including peripheral keratolysis and scleral melting.13 Although these effects have not been shown to occur in cases of topical MMC use during surface refractive surgery, some concern still exists for MMC long-term toxicity to keratocytes, endothelial cells, and intraocular structures. Some studies have reported a decrease in endothelial cell count and detection of MMC in the anterior chamber in eyes that had received MMC after surface laser ablation.



http://bjo.bmj.com/content/93/12/1634.full.pdf

 
Promises PDF Print E-mail

The Promise of Refractive Surgery: A Promise Not Kept

An Insiders Journal on the Evolution and Misinformation of Refractive Surgery

Dedicated to:

And the thousands of others whose quality of life has suffered greatly as a result of

believing the professionally communicated promise of refractive surgery

Read more...
 
An Eye Doctor's Fly in the Ointment PDF Print E-mail

"Dr. X, for every patient you send to our laser center, we'll collect the $5000 and we'll make sure you get back $2000."

"That's an extravagant amount," I said. "Isn't that a kickback?"

"So many people walk around with a meaningless life.  They seem half-asleep, even when they're busy doing things they think are important.  This is because they're chasing the wrong things.  Morrie Schwartz, "tuesdays with Morrie"

Read more...
 
Silence is Golden...for the LASIK Doctors? PDF Print E-mail
As Angry Patients Vent Online, Doctors Sue to Silence Them

By DAVID KESMODEL

THE WALL STREET JOURNAL ONLINE - September 14, 2005

Doctors have long accepted that their patients share opinions about the care they have received, knowing that satisfied patients will refer others while those not so happy with their bedside manner might encourage prospective customers to seek treatment elsewhere. But when William Boothe, an ophthalmologist in Texas, saw that one disgruntled former patient was posting his complaints on the Internet, he launched an aggressive response. He sued for libel and other claims, and earlier this year a state judge ordered the material removed from the Web.  (See documents below)

READ MORE - Subscription required
 
When doctors sue to silence PDF Print E-mail
WHAT ARE THEY HIDING?!? See the Nevyas Eye Associates, Dr. William Boothe, & Dr. Nicholas Caro sections of this site.
 
Subject: Lasik, Bausch & Lomb, & TLC PDF Print E-mail

My thoughts: A letter written regarding B&L

For 14 years I was involved in the development of the MicroKeratome that were marketed by Bausch & Lomb. I had a great deal of experience with TLC when I worked as the service department supervisor for Bausch & Lomb. 13 years ago I started worked on the prototypes for the ACS MicroKeratome and 3 years ago I was there when Bausch & Lomb bought Hansa Research & Development Corporation, the true developer.

I was the production supervisor in charge of manufacturing parts up until May of 2002. I actually had a hand in the development of the ACS and Hansatome. I am probably one of the top 5 individuals with the most knowledge about its problems and shortcomings. I was discarded during restructuring in May as the local plant began a series of cutbacks.

About TLC? MicroKeratome returned for service from TLC were some of the worst kept medical devices imaginable. Dirty and beat up by a group of doctors that share equipment like you rent bowling shoes. The problem with a group of people sharing the use of delicate equipment is that nobody cares about its upkeep. Units were treated like tools, wrenches and screwdrivers, and tossed around like the toolbox in the trunk of your car. The people at TLC were the worst to deal with. Demanding quick fixes to destroyed equipment and the blame was always the equipment never the user.

Bausch & Lomb has now developed it's own more serious problems. In January of 2001 a new plant manager took over the facility here in
Miami, Florida where the first MicroKeratome was built and where the Hansatome is produced.

From then till now that facility has undergone a series of cutbacks that affected quality and will be the end of the Hansatome project. That new manager had a personal falling-out with the previous manager and decided to replace the entire power structure of the facility to spite him. He has now done that by neutralizing 5 key people. Unfortunately for the project he has neutralized the supporting knowledge base. The people building Hansatomes were once surgical instrument makers and machinist. Now the device is built by housewives and teenagers in an assembly line production. You can figure out what happened to the quality.

Anyway this last year the production has gone down hill fast and here is a copy of my letter to the FDA in June, I fear they will not take is seriously. This facility needs attention.:

Bausch & Lomb Miami

The Bausch & Lomb facility at

7790 NW 55th St.
in Miami Florida is engaged in the production of the surgical instrument known as the Hansatome Micro Keratome. In this last year the quality of the product has deteriorated to a dangerous level. This effort to reduce cost, cut corners and implement assembly line type manufacturing has now out weighed the need to maintain quality, in this product that actually cuts the human eye. Actual patient injuries have occurred as a result of this effort to cut cost while boosting output. The Repair Dept. covers those tracks. Micro Rings and Micro Heads are being produced in volume without the necessary Quality Controls. The current Quality Manager is in the process of being replaced for voicing his concerns.

The rush to bring the new Z-Heads, Micro Suction Rings and the new 20MM Micro Suction Rings into production, was driven by Marketing and should have required a new 510(k). All other factors take a back seat to that need to hit the market with a new generation device. We are engaged in developing the new prototypes and at the same moment the plant manager is cutting resources. Reducing wages for supervisors and reduced hours for employees.

Reduced availability of tools and equipment. Cutting corners. Gages, measuring tools and cutting tools are in short supply. SPC is non existent and created after the fact as needed.

The design measurements and calculations for the calibration of the Z-Heads are flawed. The prototypes used in the clinical tests were re labeled
several times since they did not produce the expected results. They did not cut the correct thickness as predicted by engineering so the numbers on the heads were changed several times. The design was never reevaluated and under pressure from the plant manager the project pushed forward to production and product release in order to meet his timeline. The actual heads used in the clinical evaluation do not match the manufacturing drawings for the release.

Many small changes have gone undocumented in the effort to push forward.

This device is claimed to cause less compression on the flap when in fact it increases the compression of the entire eye and it is much greater pressure than the ACS unit. Several design changes have inched the Micro Keratome head closer to the eye increasing the IOP. So many Micro Heads were produced so fast that the documentation could not keep up causing heads with similar labels in inventory to have differing dimensions. This creates confusion when calibrating and installing these heads in new and service units.

The manufacturing process for Micro Suction rings and the new 20MM Ring has never been perfected even though production of the rings has increased. The development suffered from cutbacks. The FAIR's on the 20mm rings were done long after the rings were in clinical testing and were not done on the same rings used in the testing. On the Micro Suction rings, discrepancies in the measurements that control the exposure of the cornea above the ring have caused many Free Flaps as noted by the service department. Quality control in the manufacturing is lacking because of increased volume and cutbacks.

Many rings have varying dimensions. Defective rings are taken out of service or modified when found in service units.

There are massive across the board discrepancies in documentation of Prints, PCPs, SOPs and manufacturing procedures that are incorrect. Actual print dimensions are in error in many cases. This is made worse by cutbacks and restrictions in an effort to save money. GMP and ISO are the goals but the facility is in a state of disarray at this moment. The employees are working blind with an ever growing pressure by the manager to produce more volume in less time. When B&L bought this company 2 years ago documentation was minimal. Much of it was created immediately by a remote engineering department in many cases by people with no knowledge of the device. It was incomplete and flawed and in need of repair. In the last 2 1/2 years only small progress has been made in correcting the documentation and in the last year that correction process has been all but abandon. Procedures for such things as Part Machining, Assemble, Heat Treating, Hardness Testing and Servicing are in need of attention. These documents are incomplete and not understood by the employees. This is due to lack of resources, cutbacks in financing and personnel, lack of proper training and the unyielding pressure to produce more with less and to do it in less time.


Steve ____
X Production Supervisor Bausch & Lomb Miami