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.
News Links

FDA Is Taking A Second Look At LASIK After 10 Years of Complaints:
http://video.ap.org/v/Legacy.aspx?partner=en-ap&g=ea31a1c3-47f6-4f79-b7b5-88b60b7d2b61&t=s60&p=enapus_enapus&&f=CAMOD

WebMD: Experts Advise NEW WARNING For LASIK:
http://www.webmd.com/eye-health/news/20080425/experts-advise-new-warnings-for-LASIK?src=RSS_PUBLIC

Alternatives To PERMANENT LASIK Surgery That You May Want To Consider:
http://www.cnn.com/2008/HEALTH/04/30/LASIK.alternatives.ap/index.html

Dallas, TX News:  LASIK Is Causing Suicides & Permanent Dry Eye Far Worse Than Contact Lenses:
http://www.dallasnews.com/sharedcontent/dws/fea/lifetravel/stories/DN-nh_LASIK_0520liv.ART.State.Edition1.464cd52.html

The Public Has The Right To Know The Truth About LASIK:
http://capecod.injuryboard.com/medical-malpractice/LASIK-and-the-Patients-Right-to-Know-.aspx?googleid=237642

FDA PANEL Is Asked:  "Is The 95% Success Rate Misrepresented?"
http://recent-business-news.com/data/articles_b17/idb2008.04.26.07.16.42.html

FOX NEWS: LASIK Now Under FED Scrutiny:
http://www.foxnews.com/video2/video08.html?videoId=6bdf68be-7048-4a62-8170-1e497251815c&sMPlaylistID=

NEW YORK TIMES: More Bad News For LASIK Doctors:
http://thelede.blogs.nytimes.com/2008/04/25/more-bad-news-for-the-LASIK-business/?hp

GOOGLE NEWS: FDA Takes Closer Look At BAD LASIK Results:
http://ap.google.com/article/ALeqM5hm4_Y2gN7uuJFU9yGiiiwV0BWDagD90936V83

CNN MONEY: LASIK is NOT Safe:
http://money.cnn.com/news/newsfeeds/articles/apwire/a0bb852cc268d5042e965b7a05771ee4.htm

FORBES: The FDA Examines "Quality of Life" of LASIK Patients:
http://www.forbes.com/forbeslife/health/feeds/hscout/2008/04/25/hscout614914.html

CNN WARNS: FDA Takes Closer Look At Patients Complaints:
http://edition.cnn.com/2008/HEALTH/04/24/LASIK.surgery.ap/index.html

WASHINGTON POST: LASIK Patients Describe Complications At FDA Hearing:
http://www.washingtonpost.com/wp-dyn/content/article/2008/04/25/AR2008042502061.html?hpid=topnews

MSNBC WARNS: FDA Examines Blurred Related Vision Problems:
http://www.msnbc.msn.com/id/24277759/

CBS WARNS: The FDA Wants To Take Another Look At The SAFETY of LASIK Surgery:
http://cbs3.com/health/LASIK.eye.surgery.2.707855.html

http://www.cbc.ca/consumer/story/2008/04/24/LASIK-panel.html

NEW YORK TIMES: Economy Slows And So Does LASIK Eye Surgery:
http://www.nytimes.com/2008/04/23/business/23LASIK-web.html?hp

ABC NEWS:  Lisa Stark Reports on the BLURRY OUTLOOK OF LASIK SURGERY:
http://abcnews.go.com/Health/BeautySecrets/Story?id=4665779&page=1

YAHOO BUSINESS: DANGERS OF LASIK EYE SURGERY:
http://biz.yahoo.com/ap/080423/LASIK_problems_fda.html?.v=1

New York Times Reporter, Abby Ellin Warns:  "TROUBLING EFFECTS OF LASIK SURGERY..."
http://www.projo.com/health/content/lb_LASIK_surgery_nyt_04-13-08_QM9BURH_v15.e092da.html

REUTERS Warns Public About LASIK Quality Being Investigated:
http://www.reuters.com/article/healthNews/idUSN1761471320080317?feedType=RSS&feedName=healthNews 

MSNBC Warns Public About LASIK Quality Being Investigated:
http://www.msnbc.msn.com/id/23689210/ 

YAHOO Warns Public About LASIK Quality Being Investigated:
http://news.yahoo.com/s/nm/20080317/hl_nm/dc_LASIK_fda_dc_1 

New York Times Warns Public About Post LASIK Quality of Vision Problems:
http://www.nytimes.com/2008/03/13/fashion/13SKIN.html?_r=1&pagewanted=1&ei=5070&en=01ec95cbca07e3e8&ex=1206158400&emc=eta1&oref=slogin 

Chicago Tribune Warns Public That LASIK Failure Rate CAN Be High:
http://www.chicagotribune.com/news/chi-LASIK_25feb25,0,7016699.story 

The North Carolina Observer Warns Public That LASIK Could Lead To Suicide:
http://www.newsobserver.com/150/story/920341.html 

"The Grey Sheet" Warns Public About LASIK Quality Being Investigated:
http://www.thegraysheet.com/fdcreports/story/search/submitSearch.do?doClear=true&subsNum=&publications=all&query=LASIK+&find_button.x=20&find_button.y=1

Did Army Surgeon, Scott Barnes, give a misleading testimony at the Emergency FDA LASIK hearing?
http://www.lasikcomplications.com/lasik-prk-refractive-surgery-in-the-military.html

 

 Hurt from LASIK surgery?  Register for free to LASIKSugeryWatch.

It is vital that patients who have had poor outcomes
from refractive surgery be represented as a group with a voice by a patient advocacy organization such as LSW.
This has never been done before and the time is right to do it now.
http://www.lasiksurgerywatch.org
 

LASIK In The News PDF Print E-mail

More LASIK & FDA Related News/Videos

video
LASIK Complications
Are Not Being
Reported To The FDA
What is LASIK?
Some Doctors Have
Stopped Doing
LASIK.
LASIK-risks lots of risks.....................................
LASIK Risks!
video
LASIK - Safe?
Effective? Risky?
Deceptive?
Reality LASIK with reality LASIK problems
True LASIK. True
Problems!
LASIK problems often have no plan B fix
No Plan B When
Complications Occur
The Dangers of LASIK - Diane Sawyer ABC
Diane Sawyer, ABC
News: The Dangers of
LASIK.
Per research, LASIK does more damage than people know
Per Research,
LASIK Does More
Damage Than
People Realize.
video
Is LASIK A "Terrible
Idea"?
video
NBC Nightly News:
Health Alert on
LASIK - Part 1
video
NBC Nightly News:
Health Alert on
LASIK - Part 2

 

CBS News: The Dark Side Of Eye Surgery - The potential risks and benefits of Lasik eye surgery is under review by the FDA. Dr. Jon LaPook reports on what happens when the popular procedure yields unexpected results.

MSNBC Video of The Today Show Special: Is Lasik Eye Surgery Really Safe?

MSNBC Video of NBC Nightly News Special: FDA Takes Closer Look at Lasik Surgery

Associated Press Article - April 28, 2008 - Analysts say Advanced Medical Optics unhurt by Lasik inquiry.

Wall Street Journal Article - April 26, 2008 - While past studies generally have found that 95% of Lasik patients are satisfied with their surgery, some patients have complained the surgery left them with damaged eyes and psychological problems.

New York Times - Associated Press Article - April 26, 2008 - In fury and despair, patients harmed by Lasik eye surgery told federal health advisers Friday of severe eye pain, blurred vision and even a son's suicide. The advisers recommended that the government warn more clearly about the risks of the hugely popular operations.

Morning Star - Dow Jones Wire Article - April 25, 2008 - An FDA panel said Friday that the agency should improve its guidance on laser vision eye surgery to better inform patients of the surgery's risks.

WebMD Article - April 25, 2008 - Patients Tell FDA Panel About Serious Side Effects From Corrective Eye Surgery.

New York Times - Associated Press Article - April 24, 2008 - Lost in the hoopla of ads promising that laser vision surgery lets you toss your glasses is a stark reality: Not everyone's a good candidate and an unlucky few do suffer life-changing side effects -- lost vision, dry eye, night-vision problems.

Wall Street Journal Article - April 24, 2008 - Laser vision surgery has helped millions of people see better without corrective lenses. But a small number of patients have experienced troubling aftereffects from the procedure, and the Food and Drug Administration has begun taking a closer look at their complaints.

  • NBC "Today Show" Coverage:
  • April 24: A decade after Lasik surgery first became available, unhappy patients like Matt Kosovolos are eager for the Food and Drug Administration to hear their grievances. NBC's Chief Science Correspondent Robert Bazell reports.
  • April 25: Millions of Americans have undergone Lasik eye surgery safely, but some suffer side effects, prompting government hearings on the procedure. TODAY's Dr. Nancy Snyderman comments.

    Disclaimer: The videos on this page are embedded directly from YouTube. If YouTube finds that these videos are copyright violation, they will be removed from this web page immediately.

  • FDA/CDRH confirms that only (3) LASIK centers have been investigated since the year 2000

    In response to Dr. Michael Patterson, the FDA responds that ONLY 3 laser facilities were inspected from 2000 to 2008. READ THE LETTER

    Corrupt LASIK Surgeons?

    SOURCE June 3rd, 2008

    The Natural News:  Dr. Marguerite B. McDonald, the former Chief Medical Editor of EyeWorld, an international publication for ophthalmologists:" 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."  Reports That LASIK Leaves About 48% of Patients With Permanent Dry Eye!

    FULL ARTICLE:

    Perfect vision without glasses or contacts sounds wonderful. Before considering having Lasik surgery, though, it would be wise to ask how many people actually do have good results and how many will suffer bad effects years after Lasik surgery. The advertisements give the impression that it's a perfectly safe -- nearly foolproof -- procedure. Nothing could be further from the truth.

    Lasik surgery for vision improvement involves cutting a flap in the eye's cornea, the clear tissue at the front of the eye, then using a laser to cut and reshape the corneal tissue under the flap.

    According to Dr. Kerry Soloman, who did a study of Lasik's safety for the American Society of Cataract and Refractive Surgery, a full five percent have poor results. These can be worse vision -- even blindness -- constant eye pain, blurred vision, dry eyes, and a variety of other distressing visual aberrations. Interestingly, people who end up with corrected vision but permanent eye pain are considered successes by the surgeons who do the procedure.

    About 48% -- nearly half –- suffer from dry eyes at least temporarily after the surgery. Because the surgery severs the cornea nerves that stimulate tear production, this has been an obvious and predictable problem.

    About 700,000 people have Lasik surgery every year. With about 5% of them having bad results, that translates to about 35,000 people who ended up worse, with pain or with visual disturbances, such as double-vision and halos around lights.

    The FDA is now investigating the risks associated with Lasik surgery, but one must wonder where the agency has been for the last 19 years, when the surgical technique was first patented. The first Lasik machine was approved by the FDA about ten years ago.

    Lasik is Just Another Industry

    The Lasik industry is like any other. Its primary motivation is profits, and this one's are enormous. The following quote is by Dr. Marguerite B. McDonald, the former Chief Medical Editor of EyeWorld, an international publication for ophthalmologists:

    "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."

    She clearly implies that the patients' welfare is of secondary importance to the doctors' profits! Dr. McDonald is a major player in the field of Lasik surgery. Think of what this implies about the safety of the process and the dishonesty inherent in many doctors doing it.

    Of course, this shouldn't be surprising. Consider all the ophthalmologists who now specialize in only Lasik surgery. Instead of putting their efforts into procedures that might help people at risk of losing their sight, they have opted to do nothing but provide a risky and unnecessary procedure.

    Long Term Results May Include Suicide

    Long term results are proving to be even worse. Lawsuits are popping up now as a result of problems developing years later.

    Colin Dorrian was a 28-year-old patent lawyer. In the summer of 2007, he killed himself, leaving a note that blamed constant pain from Lasik surgery. He wrote, "I just cannot accept the fact that I'm supposed to live like this."

    Within the industry, there is complete denial of any cause-and-effect between Lasik and suicide. Of course, there have been no studies to see if there's a connection.

    One optometrist, Chistine Sindt, who is also a University of Iowa associate professor of clinical ophthalmology, says that she has seen depression in people with vision problems caused by Lasik. "It's not just that they lose vision. They paid somebody... who took their vision away."

    Naturally, the Lasik industry explains this sort of thing by saying that the people who become depressed suffered from psychological problems before the surgery. One would think, though, that any doctor whose first interest is in the patient's welfare would want to err on the side of caution. Instead, though, there has been denial.

    Permanent Pathological Changes in All Lasik Patients

    In a study published by Cornea in January 2005, it was reported that, of 25 post-mortem Lasik patients, every single one of them had suffered pathological corneal changes that were permanent. There were no exceptions. These patients had died between 3 months and 7 years after their surgeries, and the only determinant for selecting a case for examination was that the person's visual status prior to the surgery was known.

    Corneas Do Not Heal Completely After Lasik

    In the September-October issue of the Journal of Refractive Surgery, a report of a study on the healing of Lasik patients reported that most do not achieve anywhere near the quality of structure that's achieved from most corneal wounds. The relative strength of the Lasik-induced wound's tissues average only 2.4% of normal tissue. Wounds gotten in an accidental manner typically develop scars with 28.1% the strength of normal tissue.

    In the Journal of Refractive Surgery's April 2007 issue, the authors stated, "The Lasik flap once cut may contribute little to the mechanical stability of the cornea and probably never completely adheres to the underlying stromal bed."

    Lasik patients are left with permanently weakened corneas. This means that they are forever at risk of permanent eye damage from relatively minor injuries. Those who are most at risk of suffering permanent damage as a result of Lasik surgery, people who are involved in highly physical sports or jobs, are the ones who are often targeted by the industry. Clearly, the best interests of the patients are not the doctors' primary concern.

    Potential Damage From Lasik Surgery

    Lasik surgery has not been in existence for long, only about ten years. Its long term effects are not yet known, but there are many reasons to be concerned.

    There are some indications that the procedure may induce cataracts. Many people, including relatively young ones, have claimed that cataracts were induced by Lasik surgery. There have not, of course, been any studies to see if there's a connection.

    Lasik procedures literally evaporate part of the cornea to produce a smooth surface. This is known to create free radicals and apoptosis (cell death and dismemberment) in the stromal, underlying, structure of the cornea. Free radicals are known to cause tumor growth. It may be decades before we see results of this damage –- or it may be entirely harmless. Only time will tell.

    In November 2007, EyeNet Magazine, a publication of the American Academy of Ophthalmology, reported ectasia, bulging of the cornea, years after Lasik surgery. Joe McFarland, MD, JD stated, "We are also just now learning of some of the long-term complications of refractive surgery, which are being reflected in new allegations and lawsuits. For example, some patients are developing post-refractive ectasia years after the procedure; this condition not only compromises vision, but also may need to be treated with a corneal transplant."

    At least one case of neuropathy to both optic nerves of a patient was noted by the journal, Opthalmology in April 2008. It is surmised that the cause was elevation of intraocular (within the eye) pressure induced by a suction ring device routinely used during Lasik procedures. It resulted in several severe vision defects.

    A consistent result of Lasik surgery is that people over age 40 who had been able to see things close to them without glasses suddenly require glasses for reading. They have only exchanged distance-vision glasses for reading glasses.

    Lasik surgery changes the cornea's shape and thickness. As a result, intraocular pressure readings, which are critical for diagnosing glaucoma, become inaccurate. This may result in lost vision from glaucoma that goes undiagnosed.

    Do You Want to Take the Risk of Lasik Surgery?

    Laser sounds so much safer than a knife, but keep in mind that it cuts as sharply as any weapon. One of the primary processes of Lasik surgery is melting part of the cornea to make it smooth. The result is that even the best possible outcome results in poor healing, leaving all, or nearly all, patients at significantly greater risk of permanent eye damage from injury. Aside from the immediate risks of seriously impaired vision and permanent eye pain, the long term risks are only now coming to light.

    Is Lasik surgery worth the risk? I'll leave that up to you.

     

    Injury Board: Announces That The FDA Will Add 4 Items To Give More Informed Consent With LASIK:

    SOURCE May 13, 2008

    Patients harmed by Lasik eye surgery met with federal health advisers to complain of severe eye pain, blurred vision and even a son’s suicide. Advisers have asked the Food and Drug Administration (FDA) to warn the American public more clearly about the dangers that can arise from the popular surgery in which doctors cut a flap in the cornea, aim a laser under it and zap to reshape the cornea for sharper sight.  More than 700,000 people undergo Lasik eye surgery annually. While most benefit by gaining 20-20 vision or better, about one percent or less suffer serious, life-changing side effects: severe dry eye, glare, the inability to drive at night, and worse vision. In one case, the results of a botched Lasik eye surgery, which should never have happened because the patient did not qualify for the surgery, led the patient to commit suicide.

     

    The FDA advisers have asked the agency to make the warnings about Lasik clearer by adding four items. First, they want the agency to add photographs depicting what people suffering from certain side effects might see, such as the glare that makes headlights look like bursts of light. Second, they want the warning to clarify how often patients suffer side effects, like dry eye, since some surgeons say there is a 48 percent chance of it happening, while others say there is a 31 percent chance. Third, the advisers want it to be made clearer the conditions that disqualify people from getting Lasik. Fourth, and finally, they would like it to be known that if nearsightedness is fixed by the surgery, it is proven that the patient will need to wear reading glasses in middle age, something that could be possibly avoided by not participating in the surgery. While no one is considering restrictions on Lasik, the FDA is joining major surgeons for a major study next year to better understand which patients have bad outcomes from the surgery.

    Some patients pay dearly in bid for better eyesight: FDA panel urges clearer warnings about Lasik surgery

    SOURCE April 26, 2008

    WASHINGTON -- In fury and despair, patients harmed by Lasik eye surgery told federal health advisers Friday of severe eye pain, blurred vision and even a son's suicide. The advisers recommended that the government warn more clearly about the risks of the hugely popular operations.

    About 700,000 Americans a year undergo the elective laser surgery. Like golf star and famed Lasik recipient Tiger Woods, they're hoping to throw away their glasses, just as the ads say.
     
    Lasik surgery patient David Shell covers his face after speaking at a Food and Drug Administration hearing in Gaithersburg, Md., Friday, on Lasik surgery.
    And while the vast majority benefit -- most see 20-20 or even better -- about one in four people who seeks Lasik is not a good candidate. A small fraction, perhaps 1 percent or less, suffer serious, life-changing side effects: worse vision, severe dry eye, glare, inability to drive at night.

    "Too many Americans have been harmed by this procedure, and it's about time this message was heard," David Shell of Washington, D.C., told the Food and Drug Administration's scientific advisers before their recommendation that the FDA provide clearer warnings. Shell held up large photographs that he said depict his blurred world, showing halos around objects and double vision, since his 1998 Lasik.

    "I see multiple moons," he said angrily. "Anybody want to have Lasik now?"

    Colin Dorrian was in law school when dry eye made his contact lenses so intolerable that he sought Lasik, even though a doctor noted his pupils were pretty large. Both the dry eye and pupil size should have disqualified Dorrian, but he received Lasik anyway -- and his father described six years of eye pain and fuzzy vision before the suburban Philadelphia man killed himself last year.

    "As soon as my eyes went bad, I fell into a deeper depression than I'd ever experienced, and I couldn't get out," Gerard Dorrian read from his son's suicide note.

    Matt Kotsovolos, who worked for the Duke Eye Center when he had a more sophisticated Lasik procedure in 2006, said doctors classify him as a success because he now has 20-20 vision. But he said, "For the last two years I have suffered debilitating and unremitting eye pain."

    The testimonies illustrated that a decade after Lasik hit the market, there still are questions about just how often patients suffer bad outcomes from the $2,000-per-eye procedure.

    But one thing is clear, said Dr. Jayne Weiss of Detroit's Kresge Eye Institute, who chairs the FDA advisory panel: "This is a referendum on the performance of Lasik by some surgeons who should be doing a better job."

    The FDA advisers -- a group of mostly glasses-wearing eye doctors -- recommended that the agency make more clear the warnings it already provides for would-be Lasik patients:

     - Add photographs that illustrate what people suffering certain side effects actually see, such as the glare that can make oncoming headlights a huge "starburst" of light.

     - Clarify how often patients suffer different side effects, such as dry eye. Some eye surgeons say 31 percent of Lasik patients have some degree of dry eye before surgery, and it worsens for about 5 percent afterward. Other studies say 48 percent of Lasik recipients suffer some degree of dry eye months later.

     - Make more understandable the conditions that should disqualify someone from Lasik, such as large pupils.

     - And spell out that anyone whose nearsightedness is fixed by Lasik is guaranteed to need reading glasses in middle age, something that might not be needed if they skip Lasik.

    That's a big reason why Weiss, the glasses-wearing ophthalmologist, won't get Lasik even though she offers it to her patients.

    "I can read without my glasses and ... operate without my glasses, and I love that," she said. "The second aspect is I would not tolerate any risk for myself. ... Does that mean Lasik is good or not good? It means Lasik is good but not for everyone."

    Lasik is marketed as quick and painless: Doctors cut a flap in the cornea -- the eye's clear covering -- aim a laser underneath it and zap to reshape the cornea for sharper sight.

    The FDA agrees with eye surgeons' studies that only about 5 percent of patients are dissatisfied with Lasik. What's not clear is exactly how many of those suffer lasting severe problems and how many just didn't get quite as clear vision as they had expected.

    The most meticulous studies come from the military, where far less than 1 percent of Lasik recipients suffer serious side effects, said Dr. David Tanzer, the Navy's Medical Corps commander. That research prompted Lasik to be cleared last year both for Navy aviators and NASA astronauts.

    No one's considering restrictions on Lasik -- but the FDA joins eye surgeons for a major study next year to better understand who has bad outcomes.

    News Stories Related to April 2008 FDA Ophthalmic Panel Meeting

    YouTube Presentations of Hurt LASIK Patients
    http://www.youtube.com/profile_videos?user=FDALASIKHearingVideo&p=v

    CRS Today: Summary of Hurt LASIK Patients
    http://www.crstoday.com/PDF%20Articles/0608/CRST0608_08.php

    Slides of Damaged Patients/Presentations
    http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4353s1-00-index.html

    Shows the FDA's text version "Summary Minutes" of speakers
    http://www.fda.gov/ohrms/dockets/ac/08/minutes/2008-4353m1.htm

    Patient Advocate, Dean Andrew Kantis, Challenges The FDA To Turn In ALL LASIK Patient Complaints:
    http://www.youtube.com/watch?v=pTAHDLAwKkw&feature=related

    April 25th, 2008:  FDA Emergency LASIK Panel Discussion Reports of Dissatisfied LASIK Patients:
    http://www.crstoday.com/PDF%20Articles/0608/CRST0608_08.pdf

    What is LASIK & Why Did The FDA Call For An Emergency FDA Panel On April 25th, 2008:
    http://www.LASIKNewsWire.com

    CBS NEWS: Katie Couric Talks About The Problems With LASIK Elective Eye Surgery:
    http://www.cbsnews.com/sections/i_video/main500251.shtml?id=4047764n

    CBS Interviews Hurt Patients Describing LASIK Results:
    http://www.cbsnews.com/stories/2008/04/23/health/main4038420.shtml?source=related_story

     
    Stem Cell Cornea Fix: Better Vision May Be In Your Own Eyes PDF Print E-mail


    Researchers Use Stem Cells From Patients' Own Eyes to Restore Sight

    ABC NEWS report June 23, 2010

    More than 1.2 million Americans suffer cornea damage from injuries and more than 40,000 people a year undergo cornea transplants to repair otherwise irreversible eyesight damage, according to the American Academy of Ophthalmology.

    But now, a new study suggests that many who suffer corneal damage by chemical burn may successfully restore their sight with transplants from their own eye stem cells.

    Researchers in Italy studied a technique to repair damaged corneas by using patients' own unscathed limbal stem cells -- found at the edge of the cornea -- to grow new tissue that was then grafted into the patient's own eyes. The experiment was tried on 112 patients with corneas damaged by chemical burns. It was successful in 78 percent of patients, according to researchers, who followed the patients for 10 years after the procedure.

    READ THE FULL STORY

     
    Side effects continue to plague LASIK patients PDF Print E-mail

    Now, as the FDA investigates, one expert admits, "We screwed up"

    SOURCE

    By Abby Ellin

    iStockphoto/Salon

    The other day I got a prescription for eyeglasses. This is not newsworthy in itself except for one thing: More than two and a half years ago I had Lasik (laser-assisted in situ keratomileusis), specifically so I could toss away the spectacles I wore for near-sightedness. I knew that eventually I would need reading glasses, but I would, I was assured, be able to see long-distance for a long time.

    Problem is, I can't.

    Not only is my vision blurred, but as I wrote in a 2008 article for the New York Times, I still see halos, and not the kinds with angels attached. It takes a good 10 minutes for my eyes to adjust to dimly lit rooms. My eyes are scratchy and as dry as the desert. Yes, before I got the surgery I signed an "informed consent" saying I understood all the possible side effects, but I certainly never knew that they might last indefinitely, and that they would be more than "annoying," as my doctor promised. But nearly three years later, they are still here. And while I could get an "enhancement" -- that's industry parlance for another surgery to correct errors -- frankly, the only thing I want near my eyes is mascara.

    According to the American Society of Cataract and Refractive Surgery, most of the 13.6 million people in the United States who have had Lasik surgery since the first lasers were approved by the FDA in 1998 are pleased with the results. But others have experienced similar, if not worse, problems than I have.

    Indeed, the estimated $2.5 billion industry has recently come under fire for its failure to acknowledge potential risks. Last spring, the FDA inspected about 50 Lasik facilities and found that many had no system in place for collecting and transmitting data to the FDA on patients’ reports of post-surgical "adverse events."

    And in August, Consumer Reports Health released the results of a survey, which found that 55 percent of Americans who've had laser vision correction surgeries are still wearing glasses or contacts some of the time. Fifty-three percent experienced at least one side effect within the first four weeks of the surgery; 22 percent of patients experienced them six months after surgery, especially dry eyes, halos, glare and starbursts around lights.

    Still, the American Society of Cataract and Refractive Surgery emphasizes that Lasik surgery, which can cost up to $5,000, has a 95.4 percent patient satisfaction rate, based on an analysis of research worldwide from 1996 to 2008, said John Ciccone, a spokesman for the organization. The researchers evaluated 19 studies involving 2,022 patients that specifically addressed patient satisfaction.

    "Based on everything we know from the literature, and everything I know from any other elective procedure, Lasik eye surgery is the most successful elective procedure performed," said Dr. Kerry Solomon, a cataract and refractive surgeon in Charleston, S.C., and a co-researcher on the study.

    The experience of patients like Jeremy Fox, 26, a college student in Rockford, Ill., who got Lasik about four years ago, seem to support this assessment. Getting the procedure, he said, was one of the best decisions he has ever made. While he does experience some starbursts, he said "it’s not bothersome at all."

    But the FDA and others are taking note of what they call "quality of life" issues. In October, the FDA, the Defense Department and the National Eye Institute announced in October a three-year effort to assess adverse effects of Lasik. The effort will involve gauging how many active-duty military patients at the Navy Refractive Surgery Center in San Diego suffered post-surgical eye problems, and a series of national, multi-center clinical trials that will study the impact on quality of life following Lasik surgery in the general population. In addition, the FDA has reopened a public docket to receive comments through Nov. 15.

    "We noted that there was little consistent evaluation of the issues," said Mary Long, an FDA spokeswoman, about the reasons for why the study was initiated.

    Erik J. Rupard, a doctor and clinical researcher with the U.S. Army, is among those who think such scrutiny is necessary. "Lasik is the Tiger Woods of medical procedures: deeply and demonstrably flawed, but so many people love it that those few of us who speak ill of it are dismissed as cranks and/or loonies," he wrote in an e-mail message. "I saw lots of dry-eye complications in soldiers in Iraq who had undergone the procedure ostensibly because contacts are too unsafe in that dusty environment, and yet the Department of Defense has done no controlled studies to look at the cost -- human and otherwise -- of these post-refractive issues. I am a clinical researcher, and I know that Lasik, a cosmetic procedure, has never been subjected to the pre- or post-marketing scrutiny that we put even lifesaving drugs through."

    Surf the Web and you can find dozens of stories from people who have had post-Lasik difficulties: dry-eye, halos, glare. Some complications have resulted in corneal transplants. Over the last few years patient activists have bombarded the FDA with anti-Lasik e-mails, complaints and petitions.

    Among them is John Hoge, 39, a businessman in Port Jefferson, N.Y., who suffered from night glare and halos and regrets not choosing the "zero risk option" of corrective lenses. A few years ago he got some experimental contact lenses that have largely taken care of the glare issue. They are expensive, he added, and are not covered by insurance.

    While the FDA's recent efforts have given some patient activists a modicum of peace, many do not feel it is enough. "By not inspecting every Lasik facility in this nation, how is the FDA to know if Lasik doctors are compliant?" said Dean Andrew Kantis, 40, a jet salesman in Fort Lauderdale, Fla., who has experienced double vision, starbursts, halos and dry eyes since getting Lasik in 1999, and operates the Web site LifeafterLasik.com.

    Some experts believe the FDA should have taken more care when the first lasers were approved in 1998. "We screwed up," said Morris Waxler, a former branch chief of the FDA’s Center for Devices and Radiological Health Office of Science and Technology from 1995 to 1999. "You know how some drugs have a black box warning --  it’s dangerous because of this, this and this -- we could have done something comparable to that. We should have looked at the worst-case impact on patients, rather than just the very good outcomes we saw in the clinical trials."

    Larry Pilot, a former associate director for compliance in the FDA’s bureau of medical devices, and currently a lawyer practicing food and drug law in Arlington, Va., agreed. "It appears that information to provide adequate informed consent was not sufficient for all prospective patients about occasions where a bad outcome could result," he said. “The present dissatisfaction rate of 5 percent is very high. Personally and professionally, I am very disappointed in the FDA."

    Spokeswoman Long refutes the notion that the FDA was errant. "The FDA has reviewed safety and effectiveness information included in the manufacturer’s applications for approval," she wrote in an e-mail message. "We found them to be safe and effective when used as indicated and will continue to monitor their safety and effectiveness, in addition to taking necessary and appropriate steps to protect the public health."

    Timothy A. Ulatowski, director of the FDA’s Office of Compliance at the Center for Devices and Radiological Health, sent out letters to Lasik ambulatory facilities last May reminding them that all risks must be mentioned in every Lasik advertisement online, in print, radio or TV.

    "As part of our ongoing review of Lasik and its impact on public health, we continue to look at various aspects of Lasik advertising and how we can better improve public health," said Long.

    Still, an informal online search showed dozens of doctors' Web sites that do not mention risks or side effects. 

    As for the new study, Larry Pilot is not impressed. "The FDA is beginning to do what should have been done 10 years ago," he said. "The bottom line here is that upwards of scores of thousands of human eyes have been irreversibly damaged unnecessarily."

    Dr. Solomon disagreed, maintaining that the FDA clinical trials on Lasik lasers were "rigorous" and "well-performed." "I think the FDA did an outstanding job at evaluating the technology," he said. "And the technology and procedure since approval have only gotten better."

    As for me, if I had to do it all over again I wouldn't. But hindsight, alas, is 20-20. 

    Abby Ellin is the author of " Teenage Waistland: A Former Fat Kid Weighs in on Living Large, Losing Weight and How Parents Can (and Can't) Help ."  She lives, works, and tries to see in New York City.

    Updated February 25, 2010

     

    Former FDA Chief of Medical Devices, Morris Waxler, PHD, Warns Public About Dangers of LASIK - Aired February 25th, 2010 on Good Morning America

    Leave it to the FDA to deny that they ‘MESSED UP’. Mr. Waxler admitted 10 years after his retirement what most LASIK casualties have been trying to say since the late 1990s. The FDA continues to downplay the risks further allowing more people to get damaged from this procedure - when is enough enough? At least Mr. Waxler has taken his time to actually talk to damaged patients on a personal level (myself included), which is more than I can say for the FDA. I commend Mr. Waxler for his honesty.

    Could LASIK Lead to 'Permanent Vision Problems'?

     

    FDA Must Stop 'Epidemic of Permanent Vision Problems,' Former Proponent Says

     

    SOURCE

    September 22, 2010

    A former Food and Drug Administration official who helped get the vision correction surgery LASIK approved back in the 1990s but later spoke out against the procedure is taking his concerns directly to current regulators at the FDA.

    Morris Waxler, who is now an independent regulatory consultant, filed a citizens petition today urging the agency to take steps to stop what he calls "the epidemic of permanent vision problems" caused by LASIK.

    Waxler's petition implores the FDA to take actions to crack down on the procedure, including issuing a public health advisory that warns the public about the dangers associated with LASIK and implementing stricter controls over LASIK device manufacturers and practitioners who perform the surgery.

    In the petition, Waxler included data that he said were evidence that "LASIK causes persistent vision problems with an overall success rate of less than 50 percent; a failure rate of more than 50 percent."

    Waxler said his change of heart came about after he retired from the FDA in 2000. He started getting complaints from people who suffered serious side effects from the procedure, including seeing halos, impaired night vision and excessive glare.

    He was surprised when he looked back at the data presented when LASIK was undergoing the approval process in the late 1990s.

    "When I looked back at that data, there was a tremendous consistency that show these problems exist in about 18 percent of people who had LASIK, most of them after I left the FDA," he said.

    Some doctors, however, say while they agree with the estimate that thousands of people have had problems after having LASIK surgery, they stress that the vast majority of people are very happy after having the procedure done.

    "Ninety-nine percent of people who have had LASIK have excellent results," said Dr. Robert Cykiert, clinical associate professor of ophthalmology at NYU Langone Medical Center. "Millions of people have had the procedure done with a high success rate."

    Doctors, Patients Say LASIK Procedure Is Safe and Effective

    One of those satisfied patients is Andy Ng of Long Island, N.Y.

    Ng had LASIK in 2004. He decided to go through with the procedure because he got tired of spending hundreds of dollars on glasses that needed special lenses and would get banged up because of his participation in sports. He also found contact lenses cumbersome and time-consuming.

    He said he already knew about the side effects before he went in for the surgery.

    "I knew for a fact I was going to have halos at night," Ng said. He added that aftewards, the halos didn't make much of a difference for him.

    "I have no other problems, such as floaters, dry eyes, etc.," he said.

    Doctors stress that LASIK is no different from any other medical or surgical procedure.

    "We always would like to have any medical procedure or surgical procedure that works 100 percent of the time, but that doesn't exist," Cykiert said.

    "Complications do happen, but it's rare, and often, we're not sure why," said Dr. Penny Asbell, professor of ophthalmology at the Mount Sinai School of Medicine.

    Doctors also say that even if a patient is an ideal candidate, the surgeon is very skilled and the equipment is top-of-the-line, problems can still occur, so it's difficult to predict whether someone will suffer from LASIK-associated side effects.

    Communication, Information Vital to Minimizing LASIK Risk

    Not everyone is a candidate for LASIK, and doctors say it's important for prospective patients to understand that. People with vision that continues to get worse, extremely poor vision, certain characteristics of the cornea and some diseases may not be suitable candidates for the procedure.

    "Doctors need to take time with a patient and get all the information they need," Asbell said. "Doctors also need to learn what the patient's expectations are. If a person wants 20/15 vision, they may not be the best candidate."

    Experts also say there are still things about LASIK that they just don't know.

    "It's very hard to quantify these side effects, such as determining how to measure how bad things like glare and halos are," Asbell said. "It's hard to pin down risk factors that differentiate the people who have problems from the ones that don't so we can try to learn more."

    "There are many things we still don't know about the cornea, such as physiology and variability in structure, so we don't know why some patients bounce back and others don't," Cykiert said.

    Cykiert also said that the thousands of people who have problems have a legitimate reason to complain to the FDA, and that information they provide can be helpful for everybody.

    "That's how we're going to make the procedure safer and better," he said.

    And that's also how there may eventually be more people like Andy Ng, who has no complaints about his LASIK experience.

    "The procedure is one of the best things out there for the eyes," he said.

    ASCRS President Denies Accusations of Former FDA LASIK Chief

    SOURCE

    In a scathing three-page letter to R. Doyle Stulting, MD, PhD, president of the American Society of Cataract and Refractive Sugeons (ASCRS), Morris Waxler, PhD, the head of the Food and Drug Administration (FDA) branch responsible for reviewing data on LASIK between 1996 and 2000, accused the ophthalmic organization of blatantly ignoring several of the risks involved in PRK and LASIK procedures.

    In the letter dated May 7, 2010, Dr. Waxler, who recently said the FDA’s approval of LASIK devices was a mistake, specifically criticizes a proposed ASCRS phase 2 keratectasia trial, claiming it is unethical and puts patients at risk of post-surgical corneal failure, induces corneal thinning and bulging, and increases the likelihood of other permanent LASIK complications.

    “The ASCRS Phase II keratectasia trial proposes doctor-induced (iatrogenic) injury in vulnerable patients in order to study iatrogenic insult, instead of mitigating thinning and bulging of the cornea by not performing LASIK and by determining how to stabilize corneas already damaged by LASIK,” writes Dr. Waxler, who goes on to say he will do everything he can to block the approval of such a study.

    In support of his claims, Dr. Waxler cites several clinical reports that, among other statistics, say 15% to 30% of LASIK patients suffer from eye pain, glare, halos, dry eyes, night vision and other problems, and 1% of LASIK patients have keratectasia.

    Dr. Waxler also accuses the FDA of being “complicit with LASIK manufacturers, ASCRS, and others in minimizing multiple permanent vision complications.” He asked for Dr. Stulting's cooperation in helping to eliminate unnecessary LASIK through more transparency about the short-term "wow" effects versus the reality of permanent eye injury.

    In a response letter dated Sept. 20, 2010, Dr. Stulting broadly denies all of the claims and accusations made by Dr. Waxler, calling his view of LASIK “misinformed, unsupported by evidence, and lacking in balance and perspective.”

    “LASIK was first approved by the FDA on your watch, following all the required FDA protocols and guidance documents created to measure safety and effectiveness.  In fact, laser vision correction is one of the most studied elective surgical procedures, with 7,830 patients representing 16,502 eyes in US FDA clinical trials from 1993 to 2005 – not to mention more recent submissions to the FDA and thousands of other patients reported in the published literature.  The FDA review process is more stringent than that of any other country in the world,” he stated.

    Addressing Dr. Waxler’s accusation that the ASCRS Phase II keratectasia trial poses a danger to patients, Dr. Stulting called the assertion “plainly wrong,” saying Dr. Waxler does not have access to the protocol he references, making it impossible for him to make a responsible, meaningful comment. “Your negative and accusatory comments are inappropriate, misleading, and without foundation,” he said.

    Dr. Stulting also said the statistics Dr. Waxler cited were inflated and inconsistent with existing data. For example, the report that Dr. Waxler’s used to claim that at least 1% of LASIK patients have keratectasia actually gave the rate of 0.66%, and even that is the highest estimate in the literature, Dr. Stulting said. Published estimates of its incidence actually range from 0.0004% to 0.66%, he said.

    Dr. Stulting also accused Dr. Waxler of manipulating data by referencing the incidence of keratectasia outside of the United States, and on another occasion referencing the results of LASIK treatments with a laser designed more than 20 years ago that is not commonly used in the United States today.

    “In summary, your letter is filled with false statements, incorrect citations of the published literature, references that do not fairly represent the existing literature, mischaracterization of a study protocol you have never seen, incorrect reference to outcomes of PRK as if they were for LASIK, citation of results for a laser designed two decades ago as if were representative of modern lasers, mischaracterization of results from older lasers as “better than most,” reference of a graph that does not exist in the reference you cite, and misrepresentations of the actual performance of modern excimer lasers for the correction of refractive errors,” Dr. Stulting said.

    Given Dr. Waxler's experience and Dr. Stulting's influence with industry, I'd be more inclined to believe Dr. Waxler!

     
    $5.6 million against Kevin Niksarli, M.D., for LASIK malpractice PDF Print E-mail

    SOURCE

    Johnson Devadas and Saramma Devadas v. Kevin Niksarli, M.D., Manhattan LASIK Center, PLLC, and NewSight Laser Center, PLLC

    New York County, Supreme Court of the State of New York Index # 107637/07

    Manhattan, NY (PRWEB) June 14, 2009 -- On Wednesday, June 10, 2009, a jury in New York City returned a verdict of nearly $5.6 million against Kevin Niksarli, M.D., for LASIK malpractice. The verdict consisted of an award of: $2,360,000 for the patient's loss of income; $3,100,000 for the patient's pain and suffering, including loss of life's enjoyment; and $120,000 for the patient's wife's claim for loss of her husband's services and consortium. This is the second largest verdict ever for LASIK malpractice.

    The lawsuit, Devadas v. Niksarli, Index No. 107637/07 (Supreme Court New York County), was commenced on May 31, 2007. The trial began on May 20, 2009, and lasted 10 days. The jury of three men and three women deliberated for 2 and one-half days. The Honorable Doris Ling-Cohan presided over the trial.

    The plaintiff, Johnson Devadas, is a pharmacist who lives and works in Queens, New York. On March 25, 2004, Dr. Niksarli concluded that Mr. Devadas was a suitable candidate for LASIK surgery. However, plaintiff's medical expert testified that he was not. Paul Donzis, M.D., and ophthalmologist and cornea specialist from Los Angeles, California, testified that prior to the elective surgery, the plaintiff had a contraindication to LASIK surgery, forme fruste keratoconus. Dr. Donzis explained that forme fruste keratoconus was a stable or abortive form of keratoconus that would not likely progress without LASIK surgery. However, as a result of the LASIK surgery, it caused the cornea to develop post-LASIK ectasia, or a progressive thinning of the cornea. Ectasia causes problems with visual quality, including blurriness, halos, double vision, glare, contrast sensitivity, starbursts and a host of related phenomena involving the distortion of light as it passes through the diseased cornea.

    In addition to Dr. Donzis, plaintiffs called Albert Lyter, Ph.D., from Raleigh, North Carolina. Dr. Lyter is a former federal agent trained in ink dating analysis. Dr. Lyter testified that Dr. Niksarli intentionally artificially aged a note in his chart concerning his purported conversation with the patient and his wife concerning the risks, benefits, and alternatives to LASIK surgery.

    Anthony Gamboa, Ph.D., also testified as an expert in vocational economics concerning plaintiff's loss of income. Dr. Gamboa is from Miami, Florida.

    Dr. Niksarli called Wing Chu, M.D., from New York City, to discuss his so-called independent examination of the plaintiff. On cross-examination, Dr. Chu testified that his version of the Hippocratic Oath, in part, translates to first do no harm to any ophthalmologist.

    Dr. Niksarli also called Peter Hersh, M.D., from Teaneck, New Jersey, as his cornea expert. On cross-examination, Dr. Hersh indicated that he only testified for defendants' counsel, who had previously represented him in his own medical malpractice case.

    The plaintiffs were represented by Todd J. Krouner, from Pleasantville, New York. In 2005, Mr. Krouner obtained the largest verdict for LASIK malpractice, in the amount of $7.25 million. See Schiffer v. Speaker, Index No. 101191/03 (Supreme Court New York County 2005).

    The defendants were represented by Neil H. Ekblom, of Clausen Miller, in New York, NY. Prior to this verdict, Mr. Ekblom's webpage boasted that he had obtained a string of 19 consecutive defense verdicts.

    For further information, please contact Todd J. Krouner at (914) 769-8700.

     
    Study: Glasses After Lasik PDF Print E-mail
    SOURCE

    They had Lasik surgery but still need glasses.

    A new Consumer Reports Health survey finds that while 80 percent of people who've had Lasik or other laser vision-correction surgery are "completely" or "very satisfied," 55 percent of those who had gone through the procedure said they still had to wear glasses or contact lenses at least occasionally.

    Although many expected this would be the case, most (61 percent) said they were disappointed about that. The majority of respondents (56 percent) say they had the surgery-often pitched as an alternative to glasses-to correct nearsightedness.

    The survey was of 793 adults who had laser vision correction surgery since 2001.

    "The typical national price (per eye) for laser vision surgery is $1,657, yet the survey reveals wide variation in costs per eye. Seven percent of consumers who reported their costs said they paid less than $499 per eye; 12 percent paid between $2,500 and $3,999 per eye; and 4 percent shelled out $4,000 or more per eye. Twenty-three percent of respondents were unsure of what they paid.

    "The surgery is not without risk: 53 percent of those surveyed experienced at least one side effect within the first four weeks of the surgery and 22 percent of patients experiencing them six months after surgery, especially dry eyes and visual symptoms like halos, glare, and starbursts around lights.

    "The majority (56 percent) of respondents had the surgery to correct nearsightedness, while others had it done for astigmatism (35 percent) and farsightedness (20 percent).

    "Satisfaction with one's surgeon is key-it strongly predicts overall satisfaction with laser eye surgery, even more so than where the procedure is performed. Thus, choosing a surgeon carefully is more important than choosing the pace of surgery. Consumer Reports Health offers detailed tips for selecting the right surgeon.

    Consumer Reports Health has noted in a previous report that some of the low prices advertised for vision surgery can be potentially misleading. Among other things, the price quoted may be for only one eye. And if a free consultation is offered, you have a right to just that.

    The U.S. Food and Drug Administration has taken a hard look at Lasik eye surgery, spurred in part by a lack of reliable data about how often side effects occur. "Laser vision correction surgery is a largely unchecked industry and consumers need to know the right questions to ask to be sure they're protected and that they're getting good quality care for their money," said John Santa, M.D., director of the Consumer Reports Health Ratings Center. "Vision correction surgery is increasingly popular but there is a concerning lack of unbiased, concrete evidence about its safety and efficacy."

    It's not easy to sort through the evidence surrounding vision-correction surgery, as much of the current available research comes from surgeons who do the procedure, and who may be more likely to publish positive results, said Santa. In addition, various surgeries and lasers offer advantages in specific circumstances, but Santa notes that the lack of well-designed comparisons makes it impossible at this time to identify one laser vision corrective surgery as better than another overall.

    Since the vast majority of consumers pay most or all of the costs of the procedures out of pocket, the new Consumer Reports Health Patient Power Tool Kit, available to subscribers, will help consumers get high quality care at the right price. The tool kit will:

    "Help determine whether you're likely to be satisfied based on your personal odds and expectations.

    "Provide detailed information from consumers who have undergone the surgery.

    "Give a safety assessment of laser vision-correction surgery, based on the latest evidence.

    "Guide you through the decision process, including key questions to ask your surgeon and red flags that should alert you about getting a second opinion.

    "Tell consumers what to expect before, during, and after the surgery.

    "Detail the costs of surgery, insurance coverage, and payment strategies.

    The tool kit is available to subscribers at www.ConsumerReportsHealth.org.

     
    Synthetic Fibers to Reverse Blindness PDF Print E-mail
    SOURCE

    Eric Bland, Discovery News

    June 1, 2009 -- Synthetic fibers can now be embedded with three, and possibly more, drugs or proteins. The new fibers could be woven into a variety of materials that have unique and novel properties -- such as reversing blindness.

    "The ultimate idea is to implant this material into the eye," said Bin Dong, a scientist from Drexel University who, along with Gary Wnek and Meghan Smith of Case Western University, detailed their work in the journal Small.

    "One protein will eat the scar tissue away, and the other will help induce the differentiation of retinal progenitor cells," said Dong.

    Previously scientists were only able to include one drug or protein inside an electrospun fiber because the two would often interact with each other in ways that would negate or modify their effects.

    To get around this limitation, the Drexel and Case Western scientists put the drugs and proteins inside tiny capsules, which stop the molecules from interacting with each other until they break apart.

    For their first tests, the scientists incorporated both bovine albumin serum (BAS) and epidermal growth factor (EGF) into the same electrospun fiber. Each molecule was also linked to a particular fluorescent dye that appears under special light. Red for BAS, green for EGF.

    A fleece or nylon that glows different colors at different times is the beginning, though. Restoring vision to the blind could be the first use for these drug- and protein-containing fabrics.

    Working with Michael Young, an ophthalmologist at the Schepens Eye Research Institute, the Drexel and Case Western University researchers are trying to create a biodegradable synthetic fabric that could return sight to blind people.

    Surgically implanted onto the retina during a 45-minute operation, the protein-equipped fabric would do two things. First, proteins in the fabric would eat away at the scar tissue created by diseases like retinitis pigmentosa and macular degeneration.

    Once that's done, other capsules would break apart and release a growth factor that would encourage cultured retinal progenitor cells on top of the fabric to create new, light-detecting cells. The nanofiber material would then provide a place for these new cells attach to and grow on. Once the cells were established -- between 24 and 48 hours -- the material would naturally degrade.

    "We've been able to show that in mice we can restore some kind of meaningful vision," said Young. "Pigs have compatible cells, and the next step is to restore vision for them as well."

    If the animal trials go well, Young estimates that it will be a minimum of three years before any human trials of the material can be attempted.

    "It sounds very exciting that they were able to incorporate multiple proteins," said Paula Hammond of the Massachusetts Institute of Technology, who works with electrospun materials.

    "This could be especially interesting for tissue regeneration and wound healing applications," said Hammond.

     
    Stem Cells to Make Lasik Obsolete PDF Print E-mail
    April 19, 2009 by

    SOURCE

    The Mice with Stem Cell Eyes

    Researchers at University of Pittsburgh School of Medicine have successful restored the vision of mice with corneal defects using stem cells treatments. The stem cells were injected directly into the cornea of the mice. Upon completion of the stem cell treatment the eyes of the mice are reported to look no different than the undamaged eyes of other mice.

    Further the musculus subjects of this corneal stem cell experiment displayed no signs of immune system rejection, even when human stem cells were used during the test. This suggests that the immune system may not discriminate against stromal stem cells in the eye even when they are not harvested from the same species.

    The main argument against stem cell research has historically been voiced by those who disagree with the destruction of human embryos for the sole purpose of stem cell harvesting. However, the research at University of Pittsburgh School of Medicine may have found a way to side step the issue. At least as far as our eyes are concerned. If mice, with one of the most robust immune systems in existence, do not reject human stem cells injected into their corneas, then it stands to reason that humans, who have a much less proactive immune system, would have no problem accepting injections of rodent stem cells.

    While for many of us having rat-eyes might not be the most appealing thought, the benefits surely outweigh the gross factor. Unlike dangerous corneal replacement surgery and Lasik (laser surgery), both of which are temporary solutions which eventually degrade, corneal stem cell therapy appears to be a permanent solution. Add the reduced risk of immune system rejection, and a near endless supply of non-morally ambiguous stem cells and we may be witnessing the end of Lasik.

     
    K-State professor awarded $1.48 million to study LASIK complications PDF Print E-mail
    SOURCE

    Contact: Gary Conrad
    gwconrad@k-state.edu
                  785-532-6662       
    Kansas State University

    Gary Conrad, a university distinguished professor at Kansas State University's Division of Biology, has received a four-year grant renewal of $1.48 million from The National Eye Institute of the National Institutes of Health to study the cornea.

    "The NIH renewal will make Conrad's grant the longest continuously funded R01 grant in the state of Kansas at 41 years," said Jim Guikema, K-State associate vice president for research.

    From the beginning, Conrad has been fascinated by the unique structure of the cornea.

    "Among all body tissues, the cornea is unique in being transparent, very highly innervated, free of blood vessels and yet composed of three layers of living cells," he said.

    Conrad's research on embryonic development of the eye has led to knowledge that could possibly improve LASIK surgery. He and his research associates have identified a difference in the connective tissue of normal corneas compared to those that have been cut during LASIK.

    LASIK, which stands for laser-assisted in situ keratomileusis, is a surgery using a laser to reshape the cornea as an alternative to wearing glasses or contact lens. During the procedure a thin-hinged flap is cut in the front of the cornea and peeled back out of the way to allow the laser to reshape the corneal connective tissue underneath the flap. When the laser is finished the flap is pulled back to its original position.

    "It was once believed that the flap would re-adhere permanently. However, the unique connective tissue of the cornea and a lack of blood vessels limit its ability to fully heal even years after the procedure," Conrad said. "A trauma to the face, such as impact from an automobile air bag provides enough force to dislodge the flap, reopening the cornea, infecting it with dirt and debris, and causing instant loss of visual acuity."

    After LASIK, differences in the structure of sugar molecules made the cornea prevent cut nerve ends from regenerating, as well as preventing the flap from re-adhering. However, the National Institutes of Health grant renewal will enable the lab group to test a possible solution that would strengthen the stromal flap and allow it to permanently bind back to the cornea after LASIK, Conrad said. It uses a combination of riboflavin and UVA light to permanently cross-link the connective tissue of the flap to the underlying corneal connective tissue. The treatment is currently in clinical trials in the U.S. for another eye dysfunction known as keratoconus.

    "The density of sensory nerve fibers that normally develop in our cornea is higher than anywhere else on the surface of our entire body," Conrad said. "However, they regenerate extremely slowly if they are cut, so if we could get those nerves to regenerate, it would be a major medical advance."

    Since the grant began in 1971, Conrad's lab group has discovered many properties of embryonic and adult corneas. He credits these accomplishments to the research professors, postdoctoral research associates, graduate students, research assistants and undergraduates in his lab who co-author many research publications that have made continuing grant funding possible.

    His closest colleagues include his wife, Abigail Conrad, a K-State molecular, cellular, and developmental biologist; Yuntao Zhang, a K-State structural carbohydrate chemist; Peter Lwigale, a 2001 K-State doctoral graduate in biology and now an assistant professor at Rice University; Scott McCall, a K-State senior in biology and biochemistry and a 2008 Goldwater Scholar from Parker, Colo.; and Conrad's first doctoral student Gerald Hart, director of the department of biological chemistry at the Johns Hopkins University School of Medicine, Baltimore, Md.

    Conrad is known for mentoring and encouraging undergraduates in his lab. As a result, Conrad has recommended McCall for a summer position in Hart's lab, researching structural chemistry.

    "Our molecular biology research is only as good as our K-State freshmen dishwashers and autoclavers, so we try to train them carefully, listen to their questions, and counsel them as our closest research colleagues," Conrad said. "They teach us many things."

     
    UK reporter seeks comments on LASIK PDF Print E-mail

    SOURCE

    Why did my fabulous laser eyes go lazy again?
    By Victoria Lambert
    07th March 2009

    Quote:
    By the next morning I had full and fantastic vision. No hitches, no pain and I honestly thought I would never look back. On a good day, I could see for miles.

    Fast-forward to 2009, and here I am wearing specs again. I can't even drive without them.

    Am I a scientific freak? Or will this reversal eventually happen to all the estimated 70,000 Britons who undertake laser eye surgery annually?


    Quote:
    Have you had a similar experience to Victoria? If so, email health@mailonsunday.co.uk

     
    Laser eye surgery – you could be risking blindness PDF Print E-mail

    SOURCE

    Monday, February 16, 2009, 09:16

    Safety lawyers are warning Somerset residents that they could be gambling with their sight if they choose to undergo laser eye surgery.

    The Association of Personal Injury Lawyers (APIL) has issued a warning stating that because the procedure is unregulated, patients could end up being treated by doctors without the right skills or experience.

    APIL chief executive Denise Kitchener said: "It is imperative to ask the right questions before undergoing laser eye surgery.

    "At the moment it is the patient's responsibility to investigate the practitioner's skills and training, and the only legal demand for doctors is that they are registered with the General Medical Council.

    "The fact the industry is not regulated in any way is shocking, as someone who is inexperienced and has no specific training in this area can perform the surgery. This means there is a huge disparity in the quality of treatment available."

    The Government's clinical watchdog, the National Institute for Clinical Excellence, says laser eye surgery should not be offered to patients routinely on the NHS, and that it is the NHS that often has to pick up the pieces when private surgery goes wrong.

    "Many injuries are the result of patients not receiving appropriate counselling, or not being able to see a qualified ophthalmologist before and after the operation," said Ms Kitchener.

    "People may not realise the practice is unregulated – it is commonplace today to see it widely advertised, and the assumption would be that it is a safe procedure. While we're sure there are many skilled practitioners, the danger comes from the ones who are not competent."

    For further information, visit the APIL website at www.apil.org .uk.

     
    Lawmakers target inferior Lasik eye procedures PDF Print E-mail

    Feb. 21, 2009
    Las Vegas Review-Journal

    By ANNETTE WELLS


    Quote:
    AB196 adds to existing law regulating refractive eye surgery centers by requiring that ophthalmologists be licensed to perform the procedures through the Nevada State Health Division.

    The bill also requires that facilities that offer refractive surgery ensure that a licensed ophthalmologist perform those procedures and that the ophthalmologist is available for preoperative and postoperative care.

    The bill also authorizes the state’s health division to issue a cease and desist order if it learned a refractive surgery facility is operating without a license.


    Link to full text of article

     
    NEI lists LASIK as a cause of cataracts PDF Print E-mail
    SOURCE
     

    Quote:
    The DLS technique will now assist vision scientists in looking at long-term lens changes due to aging, smoking, diabetes, LASIK surgery, eye drops for treating glaucoma, and surgical removal of the vitreous gel within the eye, a procedure known to cause cataracts within six months to one year.

    Full text of the press release:

    For Immediate Release
    Thursday, January 8, 2009

    National Eye Institute
    496-5248

    Katherine K. Martin
    NASA Glenn Research Center
    216-433-2406


    From Outer Space to the Eye Clinic: New Cataract Early Detection Technique

    Patients and Astronauts Benefit from NEI-NASA Collaboration

    A compact fiber-optic probe developed for the space program has now proven valuable for patients in the clinic as the first non-invasive early detection device for cataracts, the leading cause of vision loss worldwide.

    Researchers from the National Eye Institute (NEI), part of the National Institutes of Health, and the National Aeronautics and Space Administration (NASA) collaborated to develop a simple, safe eye test for measuring a protein related to cataract formation. If subtle protein changes can be detected before a cataract develops, people may be able to reduce their cataract risk by making simple lifestyle changes, such as decreasing sun exposure, quitting smoking, stopping certain medications and controlling diabetes.

    “By the time the eye’s lens appears cloudy from a cataract, it is too late to reverse or medically treat this process," said Manuel B. Datiles III, M.D., NEI medical officer and lead author of the clinical study. "This technology can detect the earliest damage to lens proteins, triggering an early warning for cataract formation and blindness."

    The new device is based on a laser light technique called dynamic light scattering (DLS). It was initially developed to analyze the growth of protein crystals in a zero-gravity space environment. NASA’s Rafat R. Ansari, Ph.D., senior scientist at the John H. Glenn Research Center and co-author of the study, brought the technology’s possible clinical applications to the attention of NEI vision researchers when he learned that his father’s cataracts were caused by changes in lens proteins.

    Several proteins are involved in cataract formation, but one known as alpha-crystallin serves as the eye’s own anti-cataract molecule. Alpha-crystallin binds to other proteins when they become damaged, thus preventing them from bunching together to form a cataract. However, humans are born with a fixed amount of alpha-crystallin, so if the supply becomes depleted due to radiation exposure, smoking, diabetes or other causes, a cataract can result.

    "We have shown that this non-invasive technology that was developed for the space program can now be used to look at the early signs of protein damage due to oxidative stress, a key process involved in many medical conditions, including age-related cataract and diabetes, as well as neurodegenerative diseases such as Alzheimer’s and Parkinson’s," said NASA’s Dr. Ansari. "By understanding the role of protein changes in cataract formation, we can use the lens not just to look at eye disease, but also as a window into the whole body."

    The recent NEI-NASA clinical trial, reported in the December 2008 Archives of Ophthalmology, looked at 380 eyes of people aged 7 to 86 who had lenses ranging from clear to severe cloudiness from cataract. Researchers used the DLS device to shine a low-power laser light through the lenses. They had previously determined alpha-crystallin’s light-scattering ability, which was then used to detect and measure the amount of alpha-crystallin in the lenses.

    They found that as cloudiness increased, alpha-crystallin in the lenses decreased. Alpha-crystallin amounts also decreased as the participants’ ages increased, even when the lenses were still transparent. These age-related, pre-cataract changes would remain undetected by currently available imaging tools.

    "This research is a prime example of two government agencies sharing scientific information for the benefit of the American people," said NEI director Paul A. Sieving, M.D., Ph.D. "At an individual level, this device could be used to study the effectiveness of anti-cataract therapies or the tendency of certain medications to cause cataract formation."

    The DLS technique will now assist vision scientists in looking at long-term lens changes due to aging, smoking, diabetes, LASIK surgery, eye drops for treating glaucoma, and surgical removal of the vitreous gel within the eye, a procedure known to cause cataracts within six months to one year. It may also help in the early diagnosis of Alzheimer’s disease, in which an abnormal protein may be found in the lens. In addition, NASA researchers will continue to use the device to look at the impact of long-term space travel on the visual system.

    "During a three year mission to Mars, astronauts will experience increased exposure to space radiation that can cause cataracts and other problems," Dr. Ansari explained. "In the absence of proper countermeasures, this may pose a risk for NASA. This technology could help us understand the mechanism for cataract formation so we can work to develop effective countermeasures to mitigate the risk and prevent it in astronauts."

    The NASA John H. Glenn Research Center is one of NASA’s 10 field centers, empowered with the resources for developing cutting-edge technologies and advancing scientific research that addresses NASA’s mission to pioneer the future in space exploration, scientific discovery and aeronautics research. Working in partnership with government, industry and academia, the Center serves to maintain the U.S. economy’s global leadership while benefiting the lives of people around the world. For more information about NASA Glenn and its programs, visit www.grc.nasa.gov.

    The National Eye Institute (NEI), a component of the National Institutes of Health, is the federal government’s lead agency for vision research that leads to sight-saving treatments and plays a key role in reducing visual impairment and blindness. For more information, visit the NEI Web site at www.nei.nih.gov.

    The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

     
    Nevada Lasik Company Investigated by State PDF Print E-mail
    Updated: Oct 29, 2008 09:10 PM EDT

    There is an update on an investigation of a local Lasik clinic. State authorities say they're nearing the end of their review of the Valley Eye Center. Colleen McCarty (Las Vegas Now/Eyewitness News) first broke the story of alleged malpractice at the clinic.

    The State Attorney General's Office plans to complete its investigation of the Valley Eye Center within the next few weeks. Investigators have been exploring allegations that the administrator of the clinic practiced medicine without a license, a claim he adamantly denies.

    Suit has been filed against the clinic alleging malpractice and to administrator Vikas Jain, fraudulent concealment. Jain, they claim, provided their pre and post operative care -- procedures that, according to the lawsuits, only a licensed doctor may perform.

    Jain lost his medical license in 2005 for harming more than 20 patients in the state of Ohio.

    CLICK HERE for the full story

     
    Lasik Surgery Results in Worse Vision and Never-Ending Pain PDF Print E-mail

    SOURCE

    According to Dr. Kerry Soloman, who did a study of Lasik's safety for the American Society of Cataract and Refractive Surgery, a full five percent have poor results. These can be worse vision -- even blindness -- constant eye pain, blurred vision, dry eyes, and a variety of other distressing visual aberrations. Interestingly, people who end up with corrected vision but permanent eye pain are considered successes by the surgeons who do the procedure.

    About 48% -- nearly half –- suffer from dry eyes at least temporarily after the surgery. Because the surgery severs the cornea nerves that stimulate tear production, this has been an obvious and predictable problem.

    About 700,000 people have Lasik surgery every year. With about 5% of them having bad results, that translates to about 35,000 people who ended up worse, with pain or with visual disturbances, such as double-vision and halos around lights.

    The FDA is now investigating the risks associated with Lasik surgery, but one must wonder where the agency has been for the last 19 years, when the surgical technique was first patented. The first Lasik machine was approved by the FDA about ten years ago.

    Lasik is Just Another Industry

    The Lasik industry is like any other. Its primary motivation is profits, and this one's are enormous. The following quote is by Dr. Marguerite B. McDonald, the former Chief Medical Editor of EyeWorld, an international publication for ophthalmologists:

    "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."

    She clearly implies that the patients' welfare is of secondary importance to the doctors' profits! Dr. McDonald is a major player in the field of Lasik surgery. Think of what this implies about the safety of the process and the dishonesty inherent in many doctors doing it.

    Of course, this shouldn't be surprising. Consider all the ophthalmologists who now specialize in only Lasik surgery. Instead of putting their efforts into procedures that might help people at risk of losing their sight, they have opted to do nothing but provide a risky and unnecessary procedure.

    Long Term Results May Include Suicide

    Long term results are proving to be even worse. Lawsuits are popping up now as a result of problems developing years later.

    Colin Dorrian was a 28-year-old patent lawyer. In the summer of 2007, he killed himself, leaving a note that blamed constant pain from Lasik surgery. He wrote, "I just cannot accept the fact that I'm supposed to live like this."

    Within the industry, there is complete denial of any cause-and-effect between Lasik and suicide. Of course, there have been no studies to see if there's a connection.

    One optometrist, Chistine Sindt, who is also a University of Iowa associate professor of clinical ophthalmology, says that she has seen depression in people with vision problems caused by Lasik. "It's not just that they lose vision. They paid somebody... who took their vision away."

    Naturally, the Lasik industry explains this sort of thing by saying that the people who become depressed suffered from psychological problems before the surgery. One would think, though, that any doctor whose first interest is in the patient's welfare would want to err on the side of caution. Instead, though, there has been denial.

    Permanent Pathological Changes in All Lasik Patients

    In a study published by Cornea in January 2005, it was reported that, of 25 post-mortem Lasik patients, every single one of them had suffered pathological corneal changes that were permanent. There were no exceptions. These patients had died between 3 months and 7 years after their surgeries, and the only determinant for selecting a case for examination was that the person's visual status prior to the surgery was known.

    Corneas Do Not Heal Completely After Lasik

    In the September-October issue of the Journal of Refractive Surgery, a report of a study on the healing of Lasik patients reported that most do not achieve anywhere near the quality of structure that's achieved from most corneal wounds. The relative strength of the Lasik-induced wound's tissues average only 2.4% of normal tissue. Wounds gotten in an accidental manner typically develop scars with 28.1% the strength of normal tissue.

    In the Journal of Refractive Surgery's April 2007 issue, the authors stated, "The Lasik flap once cut may contribute little to the mechanical stability of the cornea and probably never completely adheres to the underlying stromal bed."

    Lasik patients are left with permanently weakened corneas. This means that they are forever at risk of permanent eye damage from relatively minor injuries. Those who are most at risk of suffering permanent damage as a result of Lasik surgery, people who are involved in highly physical sports or jobs, are the ones who are often targeted by the industry. Clearly, the best interests of the patients are not the doctors' primary concern.

    Potential Damage From Lasik Surgery

    Lasik surgery has not been in existence for long, only about ten years. Its long term effects are not yet known, but there are many reasons to be concerned.

    There are some indications that the procedure may induce cataracts. Many people, including relatively young ones, have claimed that cataracts were induced by Lasik surgery. There have not, of course, been any studies to see if there's a connection.

    Lasik procedures literally evaporate part of the cornea to produce a smooth surface. This is known to create free radicals and apoptosis (cell death and dismemberment) in the stromal, underlying, structure of the cornea. Free radicals are known to cause tumor growth. It may be decades before we see results of this damage –- or it may be entirely harmless. Only time will tell.

    In November 2007, EyeNet Magazine, a publication of the American Academy of Ophthalmology, reported ectasia, bulging of the cornea, years after Lasik surgery. Joe McFarland, MD, JD stated, "We are also just now learning of some of the long-term complications of refractive surgery, which are being reflected in new allegations and lawsuits. For example, some patients are developing post-refractive ectasia years after the procedure; this condition not only compromises vision, but also may need to be treated with a corneal transplant."

    At least one case of neuropathy to both optic nerves of a patient was noted by the journal, Opthalmology in April 2008. It is surmised that the cause was elevation of intraocular (within the eye) pressure induced by a suction ring device routinely used during Lasik procedures. It resulted in several severe vision defects.

    A consistent result of Lasik surgery is that people over age 40 who had been able to see things close to them without glasses suddenly require glasses for reading. They have only exchanged distance-vision glasses for reading glasses.

    Lasik surgery changes the cornea's shape and thickness. As a result, intraocular pressure readings, which are critical for diagnosing glaucoma, become inaccurate. This may result in lost vision from glaucoma that goes undiagnosed.

    Do You Want to Take the Risk of Lasik Surgery?

    Laser sounds so much safer than a knife, but keep in mind that it cuts as sharply as any weapon. One of the primary processes of Lasik surgery is melting part of the cornea to make it smooth. The result is that even the best possible outcome results in poor healing, leaving all, or nearly all, patients at significantly greater risk of permanent eye damage from injury. Aside from the immediate risks of seriously impaired vision and permanent eye pain, the long term risks are only now coming to light.

    Is Lasik surgery worth the risk? I'll leave that up to you.

    References:

    LasikDisaster, (http://lasikdisaster.com/studies.htm)

    Associated Press, ((http://hosted.ap.org/dynamic/stories/L/...)

    Washington Post, ((http://www.washingtonpost.com/wp-dyn/co...)

    Columbia Tribune, ((http://www.columbiatribune.com/2008/Feb...)

    About the author
    * Heidi Stevenson, BSc, DIHom, FBIH
    * Fellow, British Institute of Homeopathy
    * Gaia Therapy (http://www.gaia-therapy.com)
    *
    * The author is a homeopath who became concerned with medically-induced harm as a result of her own experiences and those of family members. She says that allopathic medicine is the arena that best describes the motto, "Buyer beware."
    *
    * Iatrogenic disease is illness, disability, and death caused by medical practice. It is common, resulting in huge costs to society and individuals. It's possible - even common - to suffer an iatrogenic illness without realizing its source.
    *
    * Heidi Stevenson provides information about medically-induced disease and disability, along with incisive well-researched articles on major issues in the modern world, so members of the public can protect themselves.

     
    Awareness of Drug-Induced Eye Toxicity Crucial for Patients, Physicians, PDF Print E-mail

    Says Public Citizen on WorstPills.org

    Article in ‘Drug Safety’ Identifies 62 Drugs That Can Cause Eye Disease

    April 1, 2008

    WASHINGTON, D.C. – Physicians and patients should be aware of the slew of drugs that can cause eye disease and be diligent in identifying potential adverse effects, Public Citizen writes in a new March posting on its WorstPills.org Web site.

    A recent paper published in Drug Safety identifies 62 drugs that can cause adverse reactions to the eye. Public Citizen summarizes the paper’s findings, highlights these reactions and describes how they relate to structures in the eye and certain eye conditions.

    The eye is composed of a plethora of different types of cells, and drugs can affect each type. The 62 drugs can cause a host of different eye diseases, including cataracts, glaucoma, eye surgery complications, eyelid and conjunctival diseases, optic nerve diseases and retinal abnormalities. Loss of color vision, blurred and impaired vision, decreased night vision, skin lesions and blindness are just some of the symptoms people who develop these diseases can experience.

    While people are aware of the undesirable effects drugs can have on organs in the body, they often don’t consider the potential risks to their eyes.

    “The eye is a crucial organ, and it is important that physicians and patients understand the risks associated with certain drugs,” said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen.

    WorstPills.org includes the full list of implicated drugs cited in the Drug Safety article. Some examples include: chloroquine and hydroxycholoroquine, used to treat rheumatoid arthritis, lupus, amoebae and malaria; the antibiotic linezolid; ethambutol, used to treat tuberculosis; corticosteroids; alpha-1 blockers, particularly tamsulosin; botulinum toxin (Botox); morphine administered intravenously or by mouth; and drugs in the anticholinergic and adrenergic categories.

    Just as patients check for drug-induced diseases in other parts of the body when starting new medications, they also should consider newly developed eye symptoms, Wolfe said. Early detection and various eye examinations are crucial, since some conditions, such as retinal damage, are reversible only during the earliest stages of the disease.

    Worst Pills, Best Pills is a monthly newsletter available in print and electronic formats through Public Citizen’s subscription Web site, www.WorstPills.org. The site has other searchable information about the uses, risks and adverse effects associated with prescription medications, including all the information contained in Public Citizen’s best-selling book, “Worst Pills, Best Pills.”

    WorstPills.org is an unbiased analysis of information from a variety of sources, including well-regarded medical journals and unpublished data obtained from the Food and Drug Administration, that allows Public Citizen to sound the alarm about potentially dangerous drugs long before they are banned by the federal government. For example, Public Citizen warned consumers about the dangers of Vioxx, ephedra, Baycol and Propulsid years before they were pulled from the market.

     
    LASIK failure toll can be high PDF Print E-mail

    SOURCE

    FDA to study effects of complications from eye surgery; some blame them for depression, suicide
    By Sabine Vollmer

    McClatchy-Tribune newspapers

    February 25, 2008

    RALEIGH, N.C.

    Patients who undergo vision-correcting laser eye surgery sign a release form with an extensive list of risks, but some researchers and former patients say a potential complication is not mentioned: depression that can lead to suicide.

    In response to patient complaints, the Food and Drug Administration plans to convene a large, national study to examine the relationship of LASIK complications and quality of life, including psychological problems such as depression.

    Malvina Eydelman, an ophthalmologist with the FDA's Center for Devices and Radiological Health, wrote in an e-mail that the scant clinical data available "failed to suggest significant problems following LASIK surgery."

    But she said the FDA wants a broad and systematic review. She wrote, "We also noted that quality of life issues related to LASIK had not been evaluated consistently, and there were few reports of well-designed studies."

    Frustration and sorrow can follow any unsuccessful surgery, but when the procedure leaves a patient with unremitting eye pain or permanently impaired vision, the emotional toll can be severe.

    One who could not endure it was Colin Dorrian, 28, a patent lawyer and aspiring medical student from suburban Philadelphia. He committed suicide last summer, six years after LASIK surgery left him with lasting visual distortions. The surgery was done at a LASIK center in Canada that has since closed.

    "If I cannot get my eyes fixed, I'm going to kill myself," he wrote in a note police found.

    In the note, Dorrian wrote that there had been other instances when he felt down. "I have other problems like most people do. But this is something else," he wrote. "As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it."

    Laser eye surgeons who treat patients with complications say they do come across cases of depression, but they don't think LASIK complications are the root cause. They say patients who exhibit depression after the procedure were likely depressed or psychologically troubled beforehand.

    "There's no cause and effect," said Dr. Steven Schallhorn, the former head of the Navy Refractive Surgery Center in San Diego and an expert on permanent visual distortions from LASIK.

    Christine Sindt, an optometrist and associate professor of clinical ophthalmology at the University of Iowa in Iowa City, has encountered the psychological effects that patients experience when they have trouble seeing.

    "Depression is a problem for any patient with a chronic vision problem," she said. But in the case of post-LASIK patients, she said, the depression is compounded by remorse.

    "It's not just that they lose vision," she said. "They paid somebody [who] took their vision away."

    Dr. Alan Carlson, a laser eye surgeon at the Duke Eye Center in Durham, built his career on correcting the vision of patients at high risk of complications. He said people at risk of depression or anxiety are generally not good candidates for LASIK. He compared them to patients who become depressed after undergoing cosmetic surgery.

    "Their motivation and expectations may reflect something they're missing in their life that they're not telling you about," he said.

    In 2006, the FDA began to look into LASIK complications and quality-of-life issues and determined more research was needed.

    A task force that includes representatives of the National Eye Institute and the National Institutes of Health has since formed to design a large study that would be conducted by laser eye surgeons across the country.

    The FDA is also planning a public meeting to discuss experiences with LASIK devices since their introduction to the U.S. market.

    Mostly safe, successful

    Since the mid-1990s, numerous studies have shown that the surgery known as laser-assisted in-situ keratomileusis, or LASIK, is safe and successful in most cases and has become more so with new technology. Most of the 1.3 million Americans who undergo the surgery every year are happy with the results. The American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery, suggests that only 2 percent to 3 percent of LASIK patients experience complications.

     
    Some link depression, failed lasik PDF Print E-mail

    Patients with impaired sight turn suicidal; surgeons reject any connection

    Sabine Vollmer, Staff Writer

    Patients who undergo vision-correcting laser eye surgery sign a release form with an extensive list of risks, but some researchers and former patients say a potential complication is not mentioned: depression that can lead to suicide.

    In response to patient complaints, the Food and Drug Administration plans to convene a large, national study to examine the relationship of lasik complications and quality of life, including psychological problems such as depression.

    Malvina Eydelman, an ophthalmologist with the FDA's Center for Devices and Radiological Health, wrote in an e-mail message that the scant clinical data available "failed to suggest significant problems following lasik surgery," but she said the FDA wants a broad and systematic review. She wrote, "We also noted that quality of life issues related to lasik had not been evaluated consistently, and there were few reports of well-designed studies."

    Frustration and even sorrow can follow any unsuccessful surgery, but when the procedure leaves a patient with unremitting eye pain or permanently impaired vision, the emotional toll can be particularly severe.

    One who could not endure it was Colin Dorrian, 28, a patent lawyer and aspiring medical student from suburban Philadelphia. He committed suicide last summer, 6 1/2 years after lasik surgery left him with lasting visual distortions. The surgery was done at a lasik center in Canada that has since closed.

    "If I cannot get my eyes fixed, I'm going to kill myself," he wrote in a note police found on his body. "I just cannot accept the fact that I'm supposed to live like this."

    In the note, Dorrian wrote that there had been other instances when he felt down. "I have other problems like most people do. But this is something else," he wrote. "As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it."

    Laser eye surgeons who treat patients with complications say they do come across cases of depression, but they don't think lasik complications are the root cause. They say patients who exhibit depression after the procedure were likely depressed or psychologically troubled beforehand.

    "There's no cause and effect," said Dr. Steven C. Schallhorn, the former head of the Navy Refractive Surgery Center in San Diego and an expert on permanent visual distortions from lasik.

    In September, The News & Observer reported on complications from lasik, a lightly regulated surgical procedure widely promoted as a quick and painless way to eliminate the need for eyeglasses. But patients across the country and in laser eye surgery hot spots such as the Triangle, where 11 laser eye surgery centers operate, say the physical after-effects can cause or aggravate psychological problems.

    Christine Sindt, an optometrist and associate professor of clinical ophthalmology at the University of Iowa in Iowa City, Iowa, has encountered the psychological effects that patients experience when they have trouble seeing.

    "Depression is a problem for any patient with a chronic vision problem," she said. But in the case of post-lasik patients, she said, the depression is compounded by remorse.

    "It's not just that they lose vision," she said. "They paid somebody [who] took their vision away."

    Sindt specializes in treating ectasia, a bulging of the eye that is considered the most severe and rarest lasik complication. She sees a few dozen patients with ectasia; all of them show signs of depression, she said.

    Lasik usually safe

    Since the mid-1990s, numerous studies have shown that the surgery known as laser-assisted in-situ keratomileusis, or lasik, is safe and successful in most cases and has become more so with the introduction of new technology. Most of the 1.3 million Americans who undergo the surgery every year are happy with the results. The American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery, suggests that 2 percent to 3 percent of lasik patients experience complications.

    But surgeons agree that lasik is unlike a face-lift or even most necessary surgery because it affects a process -- seeing -- that is essentially a mental function. The eyes focus light, but what a person actually sees depends on how the brain decodes an image. Neurological differences in decoding explain why dyslexics reverse letters and why alcohol consumption can produce double vision.

    Although laser eye surgery has been around for years, little research has been done to explore how the ability to see affects how people feel and act. In 2006, the FDA began to look into lasik complications and quality-of-life issues and determined more research was needed. A task force that includes representatives of the National Eye Institute and the National Institutes of Health has since formed to design a large study that would be conducted by laser eye surgeons across the country.

    Vision-mind connection

    The FDA is also planning an open public meeting this spring to discuss experiences with lasik devices since their introduction to the U.S. market.

    A few researchers have already looked at whether changes in vision can affect the mind. Scientists at the Emory Eye Center in Atlanta reviewed suicides among organ donors who had had laser eye surgery.

    Preliminary results suggested the suicide rate might be four times as high among cornea donors who had had lasik as among cornea donors who had not. But the data were incomplete and the numbers could be significantly skewed, said Dr. Henry Edelhauser, the professor of ophthalmology who oversaw the Emory study. One of the participating eye banks failed to provide vital statistical data.

    Research that Schallhorn did at the Navy Refractive Surgery Center suggests a relationship between satisfaction after lasik and certain personality traits among patients. Schallhorn declined to provide details. Like the results of the Emory suicide study, his research has not been published in peer-reviewed journals.

    But some patients are unequivocal: Lasik complications drove them to contemplate suicide.

    In Cleveland, Tenn., Kim Hybarger, 44, a nurse, developed debilitating visual distortions after lasik surgery Dec. 21, 2006. She tried to walk into traffic, cut her throat and starve herself.

    "I was filled with anger," she said. "I felt so hopeless and helpless. I just wanted to die. The way I saw was so frightening."

    Hybarger's mental state didn't improve until Ed Boshnick, a Miami optometrist, offered to fit her with special contact lenses.

    Sales of the special lenses have increased with the rising number of Americans who had lasik since 2000. The lenses can restore the cornea's shape and correct visual distortions.

    New lenses help

    Boshnick is one of a handful of specialists who have had considerable success fitting the lenses. Hybarger is one of about 250 patients with complications from lasik who regularly see Boshnick. About half of them suffer symptoms of depression, Boshnick said.

    The new lenses can clear up more than vision.

    Hybarger left Miami remembering the moment she first looked through them.

    "It was indescribable," Hybarger said. "It was like the first time I smiled in a year."

    The complete article can be found HERE.

     
    2 New Lenses For Post Refractive Surgery PDF Print E-mail

    Optometrists and ophthalmologists that work with post-op LASIK problems have 2 brand new lenses at their disposal.

    First, J&J Acuvue OASYS now comes in a brand new 8.8 mm base curve, which fits flat on normal eyes but fits well on surgically flattened RK or LASIK eyes.

    Second, SynergeyesPS is the first FDA-cleared hybrid contact lens especially designed for patients with oblate corneas resulting from
    refractive surgery.

     
    Singapore halts Lasik surgery after inflammation cases PDF Print E-mail

    SCIENCE NEWS

    March 14, 2007

    A key Singapore eye hospital has suspended Lasik eye-sight correction surgery after a surge in the number of patients suffering from inflammation.

    The Singapore National Eye Center (SNEC) halted all Lasik surgeries last week after 17 patients suffered from the Diffuse Lamellar Keratitis inflammation following treatments, according to Ravi Chandran, the center's spokesperson said on Wednesday.

    "SNEC has recently seen an unusual increase in inflammatory reaction in patients after lasik treatment," Chandran said, adding that the cause of the inflammations is still unknown.

    Singapore is trying to establish itself as a medical center for foreigners. Some 200,000 overseas patients seek medical care in Singapore each year, more than half of them from neighboring Indonesia.

    Patients who suffer from the Diffuse Lamellar Keratitis inflammation do not experience any pain or discomfort, but may have blurry vision for one to two weeks, Chandran said.

    The suspension, which is the first-ever in the Southeast Asian city-state, is expected to at least last until the end of the month, according to Chandran.

     
    Beta-Blocker Eye Drops Can Cause Serious Adverse Reactions PDF Print E-mail

    Public Citizen Reveals on WorstPills.org Web Site

    “Worst Pills, Best Pills” Readers Also Receive Life-Saving Warnings About Dangerous Drugs Before They Are Removed From the Market

    WASHINGTON, D.C. – Beta-blocker eye drops, used for treatment of blindness-causing glaucoma, may cause significant adverse effects such as death, heart attack, serious drops in blood pressure, fainting spells and other complications, Public Citizen writes in a new November posting on its WorstPills.org Web site. The consumer advocacy organization cited information published in the September 2 issue of The Lancet.

    To read the entire press release, click here.

     
    Consumers Often Overdose on Prescription Eye Drops PDF Print E-mail

    Public Citizen Reveals on WorstPills.org Web Site

    Sept. 1, 2006

    WASHINGTON, D.C. – Though many eye drop prescription labels instruct patients to use one or two drops, consumers should only use one drop because there is a lesser risk of overdosing, Public Citizen writes in a new September posting on its WorstPills.org Web site. The consumer advocacy organization cited information published in the June 19 issue of The Medical Letter on Drugs and Therapeutics.

    The volume of liquid contained in one eye drop varies with the thickness of the solution, the design of the dropper and the way in which the patient uses the dropper to dispense drops. By administering a second drop, consumers could lower the effectiveness of the first drop by flushing it out or increase the risk of having an adverse reaction by allowing the medication in the drops to enter the blood stream.

    A human eye can hold up to 10 microliters of liquid at a time, whereas a single droplet from an eye dropper can range from 25 to 50 microliters. The excess medicine has only two places to go – streaming down the patient’s face in harmless, but expensive, tear-like rivulets or through a small duct in the corner of the eye and into the nose, where it is absorbed into the blood and distributed to the rest of the body.

    The full story can be read HERE

    For information on opthalmic conditions such as eye infection, eye inflammation, increased eye pressure, eyelid infection, and dry eyes, please visit Public Citizen's Worstpills.org website.

    “Worst Pills, Best Pills” Readers Also Receive Life-Saving Warnings About Dangerous Drugs Before They Are Removed From the Market

     
    Fusarium Keratitis --- Multiple States, 2006 PDF Print E-mail

    Fusarium Keratitis --- Multiple States, 2006

    On March 8, 2006, CDC received a report from an ophthalmologist in New Jersey regarding three patients with contact lens--associated Fusarium keratitis during the preceding 3 months. Initial contact with several corneal disease specialty centers in the United States revealed that other centers also have seen recent increases in Fusarium keratitis. This report summarizes the public health response to date in the United States and provides important prevention messages for contact lens users.

    Microbial keratitis is a severe infection of the cornea. Risk factors for infection include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiencies, and rarely, contact lens use (1--3). An estimated 30 million persons in the United States wear soft contact lenses; the annual incidence of microbial keratitis is estimated to be 4--21 per 10,000 soft contact lens users, depending on whether users wear lenses overnight. Fungal keratitis is a condition more prevalent in warm climates; in the southernmost United States, up to 35% of microbial keratitis cases are fungal keratitis, compared with 1% in New York. The proportion of fungal keratitis attributable to Fusarium spp. also varies by region, from 25% to 62%. First-line treatment includes topical and oral antifungal medications; patients who do not respond to medical treatment usually require surgical intervention, including corneal transplantation. Fusarium keratitis is not transmitted from person to person.  As of April 9, 2006, a total of 109 patients with suspected Fusarium keratitis were under investigation in multiple states.  On April 10, this report was posted as an MMWR Dispatch on the MMWR website.

    Read more at their website…(http://www.cdc.gov/mmwr).

     
    Bausch & Lomb PDF Print E-mail

    Bausch & Lomb recalls second contact lens solution

    March 2007 - Bausch & Lomb, which has been struggling to recover from a sweeping recall of its ReNu with MoistureLoc contact lens solution, said on Tuesday it had initiated a recall of certain lots of its ReNu MultiPlus contact lens solution.

    The company advises consumers to discard any lens care solution that appears to be discolored. The recalled lots all carry the expiration date "2008 - 03" on the bottle.

    Read More

    Bausch & Lomb Still Unsure Of Mystery Fungus

    The company halted U.S. shipments of its ReNu with MoistureLoc contact lens solution Monday night while the Centers for Disease Control and Prevention investigates 109 reports of infection caused by a fungus called Fusarium in patients in 17 states.

    The agency has made no direct link between ReNu and the infections, traced back to June 2005, but a high incidence of the affected people had used the solution. 

    Bausch & Lomb, which also makes contact lenses, ophthalmic drugs and vision-correction surgical instruments, stopped short of pulling the brand, made at its factory in Greenville, S.C., but merchants led by Wal-Mart Stores Inc. began removing it from store shelves Tuesday. 

    Fusarium is commonly found in plant material and soil in tropical and subtropical regions. Without eye-drop treatment, which can last two to three months, the infection can scar the cornea and blind its victims. 

    Symptoms can include blurry vision, pain or redness, increased sensitivity to light and excessive discharge from the eye. It is not transmitted from person to person. 

    In February, Bausch & Lomb stopped shipments of ReNu in Singapore and Hong Kong after a similar spike in fungal infections was reported in contact-lens wearers there. It is partnering with health authorities and researchers to investigate the extent and cause of the outbreak, which also surfaced in Malaysia. 

    More than 30 million Americans wear contact lenses, and the ReNu brand generated $45 million in U.S. sales last year. 

    You can read more at the following link:

    http://www.cbsnews.com/stories/2006/04/12/health/main1493941.shtml?source=RSS&attr=Health_1493941ource=RSS&attr=Health_1493941

     

    This posting was found on a Yahoo Message board 05/03/06 for Bausch & Lomb:

     

    SOURCE

     

    10:43 ET Bausch & Lomb: CDC updates investigation; more than MoistureLoc appears to be at risk - Baird (BOL) 44.20 -4.55: -Update- Baird says the CDC has updated information on 58 fungal keratitis cases (56 contact lens wearers). Of the 56, 57% used ReNu MoistureLoc, 27% Multiplus, and the rest an unknown ReNu product. Firm notes that the association with MoistureLoc and now MultiPlus is far greater than any other competing solutions (to date, firm has yet to confirm that any fungal infections were associated with the exclusive use of a non-BOL solution), and therefore remain concerned that the entire ReNu franchise -- not just MoistureLoc -- could be at risk. As a reminder, firm has already removed what they believe are the vast majority of ReNu (including MoistureLoc and MultiPlus) sales from their 2006-07 ests, and therefore are making no changes at present to their model.

     

     
    Potential intraocular side effects of ocular steroids PDF Print E-mail

    Quote: The potential intraocular side effects of ocular steroids are well known and include a rise in IOP and the formation of cataracts.

    EyeWorld

    February 2006

    SOURCE

     
    Long-term LASIK Concerns Expressed PDF Print E-mail

    Critical Preop Calculation

    Full Article

    Sunday, December 17, 2006

    Millions of Americans have undergone refractive surgery (RK, PRK, LASIK, LASEK, INTACS, etc.) to reduce or eliminate their need for glasses and contact lenses.

    Millions of other Americans receive cataract surgery every year for removal of a cloudy lens. An artificial intraocular lens (IOL) is implanted to substitute for the natural lens.

    Now, these two groups of patients are beginning to collide and it's not very pretty!

    Prior to cataract surgery precise measurements and calculations must be performed to determine the appropriate IOL lens power. Measurements include items like the current refractive error and the central corneal curvature. Data is entered into a sophisticated formula using customized computer software. These formulas assume the eye is healthy and has never had previous surgery.

    Now, a backstage peek: IOLs are stored in cabinets and organized by different lens powers (+ or - diopters in nearly every power imaginable) just like a shoe store. Miscalculate the IOL power and the patient cannot see clearly afterwards - even if the surgery itself was flawless.

     

     
    Factors consumers should weigh when eyeing surgery PDF Print E-mail

    SOURCE

    By Washington PostDec 26, 2006 - 06:42:16 am PST

    While results have improved for laser eye surgery patients, experts warn that the decision to have surgery should never be made without careful consideration of the potential risks. Lasik and similar procedures are not approved for patients younger than 18, because their vision has not stabilized.Here are some factors consumers should consider: -- Some people complain that although they see 20/20 on the eye chart after surgery, their vision is not as crisp as it was with contacts or glasses. People with large pupils and those who are very nearsighted may develop glare or halos, especially at night. Others may have trouble discerning contrast.

    -- Serious complications are rare -- ranging from about 1 to 2 percent of patients, depending on surgeon experience -- but they do occur. Some are permanent.

    -- If you participate in contact sports, Lasik may not be advisable because a blow to the face could dislodge the corneal flap. PRK, a more painful procedure that involves several days of healing time, may be preferable because there is no flap.

     

     
    Technology widens eye surgery pool, but skeptics remain PDF Print E-mail

    Seeing the big picture

    Sun, Dec. 24, 2006

    "But not everyone is enamored of the new technology. David Hartzok, an optometrist in Chambersburg, Pa., specializes in treating people with complications from laser surgery. He also directs the Vision Surgery Rehab Network, an advocacy group for patients with post-operative problems.“The people I see coming in today are the products of the new technology, and they’re having the same problems,” such as dry eye, glare, starbursts and blurred vision, Hartzok said. “I do think in general surgeons are more circumspect about the kinds of patients they do and lasers are better.” But that, he said, is no guarantee of a good result."

    Full article

     
    Warning from the BBB and FTC PDF Print E-mail

    Lasik eye surgery is one of the newest procedures to correct vision problems. But, before you sign up for the surgery, the Better Business Bureau, along with the Federal Trade Commission, suggests you know the facts.

    Many people rely on glasses and contacts to correct their vision, but some find these methods inconvenient, uncomfortable or unattractive.

    Read More

     
    More News & Inside Stories from the Laser Eye Surgery Industry: PDF Print E-mail

    LASIK, PRK, LASEK, and ICLs

    Read More

     
    Study: Some See Stars After LASIK PDF Print E-mail

    LASIK surgery might not be the miracle sight cure some patients expect, according to a new study.

    Nearly one-quarter to one-third of patients who underwent LASIK surgery reported problems seeing at night, a new study reported.

    Read More

     
    The National Institute for Health and Clinical Excellence (NICE) has issued guidance on PDF Print E-mail

    Photorefractive (laser) eye surgery:

    for the treatment of refractive errors (short and long-sightedness) to determine whether it is safe enough and works
    well enough for use. The guidance does not recommend that laser eye surgery should be offered to patients routinely on the NHS, as for most people eye problems can easily be corrected by wearing spectacles or contact lenses.

    In summary the guidance states that:

     - Current evidence suggests that laser eye surgery is safe enough and works well enough for use in appropriately selected patients.

     - Clinicians wishing to undertake laser eye surgery should ensure that patients understand the benefits and potential risks of the procedure. Risks include failure to achieve the expected improvement
    in unaided vision, development of new visual disturbances, corneal infection, and flap complications. These risks should be weighed against the risks and any possible inconvenience of wearing spectacles
    or contact lenses.

     - Clinicians should audit and review clinical outcomes of all patients who have laser eye surgery. Further research will be useful and clinicians are encouraged to collect longer-term follow-up data.

     - Clinicians should have adequate training before performing these procedures. The Royal College of Ophthalmologists has produced standards for laser refractive surgery.

    Read more at their website: http://www.nice.org.uk/pdf/2006_012_NICE_issues_guidance_on_laser_eye_surgery.pdf

     
    Sensitivity of the NEI Refractive Error Quality of Life instrument to RS outcomes PDF Print E-mail

    J Cataract Refract Surg. 2005 Dec;31(12):2313-8.

    Nichols JJ, Twa MD, Mitchell GL.

    From the full text (you won't see this in the abstract):

    Quote:

    "One might also predict these 2 groups to report a significant difference in glare. However, the design of the clinical trial for these LASIK patients limited enrollment to those who were unlikely to experience this problem (ie, low to moderate myopia and pupil sizes less than 7.5 mm)."

    There is something terribly wrong with this picture. They exclude high myopes and patients with large pupils in their "quality of life" survey in order to make LASIK look good. Some in the industry keep saying pupil size doesn't matter and others say there's still debate on whether or not pupil size matters. But if pupil size didn't matter, why not include patients with large pupils in these surveys?

    It's all just a big cover-up. They know good and damn well pupil size matters.

     
    Low light problems such as glare and halo occur in some 3-5% of patients after PRK or LASIK PDF Print E-mail

    The 3 commonest reasons for this are:

    Read More

     
    Known Risk Factors for Ectasia PDF Print E-mail

    Cataract & Refractive Surgery Today

    October 2005

    http://www.crstoday.com/PDF%20Articles/1005/CRST1005_F3_Trattler.html

     
    "Ectasia is one of the most feared postoperative complications of LASIK," PDF Print E-mail

    said Dr. Behrens, cornea surgeon and researcher at the Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore.

    "While its incidence appears to be low, it is a devastating occurrence for patients with healthy eyes who are undergoing an elective surgical procedure," Dr. Behrens said at the meeting sponsored by the Johns Hopkins University School of Medicine, Baltimore, and Ophthalmology Times. "Importantly, available information indicates we are currently lacking an accurate method to identify patients at increased risk."

     
    Still Newsworthy PDF Print E-mail

    University partners with industry to assist patients injured by Lasik - Read More

    Lasik risks understated - Read More

    Washington Post Articles - Read More

    The American Academy of Ophthalmology says that very short-sighted people "should not have" LASIK eye surgery - Read More

    Prevention may be best strategy for managing post-LASIK dry eye - Read More

    More LASIK related articles from Ophthalmology Times (Type in LASIK in search box) - Read More

    A new study by US researchers reveals that as many as one in five LASIK patients need a second treatment (May, 2003) - Read More

     
    Palmer Awarded Damages After Failed Eye Surgery PDF Print E-mail

    A Palm Beach, FL County jury sided with Hall of Fame pitcher Jim Palmer yesterday, finding an ophthalmologist liable for damage to Palmer's vision and awarding him $890,000.

    His attorney, Gary Cohen, said Palmer was talked into a getting a multifocal intraocular lens in his eye that isn't made for people who work at night. That lens was later taken off the market, Cohen said.

    After the cataract surgery, there were signs of retinal tears that should have prompted further examination but were instead ignored and led to a detached retina, Cohen said. Palmer still suffers from vision problems that have affected his ability to work, as many games are held at night.

    Undergoing a reattachment surgery was "pretty scary," Palmer said, not knowing whether he would be able to see when the surgery was over.

    The jury awarded $327,000 in lost earnings and $563,000 in past and future pain and suffering.

    The full story can be found HERE

     
    LASIK volume up more than 25%, ASCRS survey finds PDF Print E-mail

    SOURCE

    WASHINGTON — The volume of LASIK procedures grew 26% from 2003 to 2004, according to an annual survey of practice preferences presented here at the American Society of Cataract and Refractive Surgery meeting.

    Other notable findings of the survey of U.S. members of ASCRS included an overwhelming preference for acrylic IOLs, a unanimous interest in accommodating IOLs and a near-doubling of the use of clear corneal incisions from 5 years ago.

    David V. Leaming, MD, sent his annual survey on general ophthalmic trends to 6,296 physicians; 773 returned the questionnaire. He reported the results of the survey here in a presentation and a poster.

    According to Dr. Leaming, in 2004, 62% of survey respondents used topical plus intracameral anesthesia in cataract surgery.

    Over a 5-year period, from 1999 to 2004, the use of clear corneal incisions almost doubled, from 40% to 72%, according to survey responses. Surgeons said they prefer a metal blade to a diamond blade by a two-to-one ratio, Dr. Leaming reported.

    As in recent years, acrylic IOLs remained the preferred IOL material among respondents, followed by silicone, PMMA and hydrogel. More than half the respondents — 57% — said they prefer a single-piece foldable IOL

    For use with ultrasmall-incision cataract surgery in the future, 38% of respondents said an acrylic lens is the most promising IOL, and 29% of respondents said an injectable lens material holds the most promise.

    In a change from last year, 61% of respondents said they prefer implanting a clear IOL rather than a blue-light-filtering IOL. In 2003 47% reported preferring clear lenses.

    The survey also addressed refractive surgery topics. As noted above, respondents reported an increase in LASIK volume by 26% in the year since the 2003 survey.

    Seventy-five percent of respondents said 250 µm is the threshold for the residual stromal bed below which they would not perform LASIK.

    Asked about what refractive procedures they were interested in adopting, 84% of respondents said they were not interested in scleral expansion, 49% were not interested in conductive keratoplasty, 54% were not interested in LASEK and 50% were interested in phakic IOL implantation.

    Respondents said they charge an average $500 additional to perform customized LASIK over their fee for conventional LASIK.

    Dr. Leaming noted that in 2003 respondents said only 9% of patients were offered wavefront LASIK. In 2004, every patient was offered the option of wavefront, he said.

    The survey respondents reported an overall post-LASIK ectasia rate of 9%.

    Regarding glaucoma, the survey posed a series of scenarios and asked what drug the respondents would prescribe. For first-line therapy in a 45-year-old patient, 60% said they would prescribe prostaglandins if the patient was blue-eyed with no cardiopulmonary complications, and 77% would prescribe prostaglandins if the patient had brown eyes and no cardiopulmonary complications. For a blue-eyed patient with a history of cardiopulmonary complications 83% would prescribe prostaglandins, and for a brown-eyed patient, 94%.

    Regarding medical liability, 17% of respondents said they pay a malpractice insurance premium of $10,000 per year; 14% each said they pay $7,500, $12,500 or $15,000.

     
    Will New FDA Approval Spur NSAIDs Interest? PDF Print E-mail

    Using NSAIDs during the preoperative period can reduce postop pain and inflammation and can provide better visual outcomes.

    Michelle Stephenson, Contributing Editor

    Vol. No: 12:06Issue: 6/15/2005

    IN LATE MARCH, THE U.S. FOOD AND DRUG ADMINISTRATION approved the new drug application for Xibrom (bromfenac ophthalmic solution 0.09%, Ista Pharmaceuticals) for the treatment of ocular inflammation after cataract surgery. Xibrom will be launched in the United States this summer.

    Currently available ophthalmic nonsteroidal anti-inflammatory drugs include three formulations of Acular (ketorolac tromethamine, Allergan), Ocufen (flurbiprofen sodium, Allergan), and Voltaren (diclofenac sodium, Novartis), and these drugs are widely used after both cataract and refractive surgery.

    The pre- and postoperative use of NSAIDs can help to ease pain and inflammation and can accelerate the return of visual acuity in cataract surgery patients. Additionally, use of NSAIDs keeps pupils dilated during surgery, which allows for quicker and less traumatic procedures.

    “Other indications in cataract surgery include the prophylaxis of cystoid macular edema, control of pain associated with clear-corneal cataract incisions, and the improvement of quality of vision after cataract surgery,” says Calvin W. Roberts, MD, clinical professor of ophthalmology at Weill Medical College of Cornell University, in New York City. “The other main indication for the use of NSAIDs is in refractive surgery to control pain after surface ablation and after incisional corneal surgery. I can’t think of any other class of medications that is effective for doing so many things.”

    NSAIDs’ Mechanism of Action

    NSAIDs inhibit the metabolic pathways of prostaglandin synthesis, which controls inflammation and pain after both cataract and refractive surgery. Intraoperatively, patients who have been given NSAIDs have less blepharospasm and discomfort.

    “With cataract surgery, one of the main advantages of nonsteroidals is that they inhibit the prostaglandin release that causes pupillary miosis, and they are very effective at maintaining mydriasis,” says Eric D. Donnenfeld, MD, an associate professor of ophthalmology at New York University Medical Center, New York City.

    Dr. Donnenfeld recently conducted a study to assess the clinical benefit, relative efficacy, and dose response curve of preoperative Acular LS (0.4% ketorolac tromethamine ophthalmic solution, Allergan) as a surgical tool in cataract surgery. He presented the study results at the annual meeting of the American Society of Cataract and Refractive Surgery in Washington, DC.

    The double-masked study included 100 patients who were randomized into four groups. Three groups received Acular LS before cataract surgery: three days, one day, or one hour preoperatively. The fourth group received placebo.

    The effect of Acular LS on maintaining preoperative mydriasis, phacoemulsification time and energy, operative time, corneal clarity, pachymetry, endothelial cell counts, postoperative inflammation, intraoperative and postoperative discomfort, intraoperative complications, and cystoid macular edema were evaluated.

    The study found that the maintenance of pupil size, phacoemulsification time and energy, operative time, corneal clarity, postoperative inflammation, and intraoperative and postoperative discomfort was significantly improved with three-day NSAID pretreatment compared to one-day pretreatment, and one-day pretreatment was significantly better than one-hour pretreatment or placebo. In fact, Dr. Donnenfeld says that patients who received Acular LS for three days preoperatively had almost 2 mm more pupillary dilation during cataract surgery compared to placebo.

    “In addition, there was a trend toward improved pachymetry on postoperative day one and endothelial cell counts at three months in the three-day pretreatment group relative to placebo. The use of NSAIDs significantly improves patient rehabilitation postoperatively, so that patients see better faster and have fewer postoperative complications,” he says.

    According to Henry D. Perry, MD, prostaglandins occur naturally in the eye and are constantly being formed. “Using an NSAID three days before cataract surgery significantly decreases the amount of prostaglandins in the eye. So, when the incision is made, there will be less of an inflammatory response, just because there are fewer prostaglandins in the eye,” says Dr. Perry, who is an associate clinical professor at Weill Medical College.

    He also notes that NSAIDs help to lessen patients’ response to painful stimuli because of their anesthetic and analgesic effects. Postoperatively, they are additive to corticosteroids for decreasing inflammation.

    NSAIDs have also been found to help patients achieve better contrast sensitivity and better quality of vision after cataract surgery. “The use of nonsteroidals preoperatively and postoperatively will decrease the amount of inflammation that occurs after surgery, and this is directly related to the quality of the vision that the patient achieves,” Dr. Roberts says.

    In his recent study, also presented at the ASCRS meeting, 200 patients undergoing routine phacoemulsification were randomized to receive Acular LS along with postoperative steroids and antibiotics, or to receive only postoperative steroids and antibiotics. Macular thickness was measured by optical coherence tomography prior to surgery and one month postoperatively, and contrast sensitivity was measured one month postoperatively. The study found that the incidence of postoperative macular edema was higher in the group that did not use Acular LS and that contrast sensitivity was decreased in the group that did not use Acular LS.

    “We concluded that the use of topical NSAID drops can reduce macular edema and improve contrast sensitivity in routine phacoemulsification, and contrast sensitivity is a better indicator of quality of vision than visual acuity after cataract surgery,” he says.

    Comparing NSAIDs

    Dr. Roberts says that the currently available NSAIDs can be differentiated by potency. Acular and Voltaren are more potent than Ocufen. “In fact, there is really no indication for the use of Ocufen,” he says.

    However, although Acular and Voltaren are potent NSAIDs, these drugs have side effects. For example, both Acular and Voltaren sting and burn on instillation. According to Dr. Donnenfeld, diclofenac’s adverse-event profile includes transient stinging and burning in approximately 15 percent of patients with up to 28 percent of patients developing keratitis, and ketorolac has an even higher rate of stinging and burning, with up to 40 percent of patients who use the old formulation experiencing discomfort.

    The incidence of burning and stinging has been significantly reduced with Acular LS. “This may sound like a small thing, but when patients use these drops for a long time, stinging becomes a big issue. Acular LS gives us the best of all worlds. It is just as effective as the 0.5% formulation, it is more comfortable, and it is more convenient because it comes in a big bottle,” Dr. Roberts says.

    He noted that some refractive surgeons prefer Acular PF (preservative-free) because they want to minimize the amount of preservatives in the eye after cataract surgery. However, he noted that the concentration of preservative in Acular LS is extremely low.

    “NSAIDs are safe drugs that have received some bad press, especially Voltaren, because of corneal complications related to the use of the drug topically in dry-eye patients. There is some concern about using NSAIDs in patients with very dry eyes, such as those with keratoconjunctivitis sicca, which is justified. However, for the most part, this class of drugs is very safe for topical use,” Dr. Perry says.

    Both Acular and Voltaren are indicated for four times daily dosing for 14 days after cataract surgery to achieve a decrease in postoperative inflammation.

    Xibrom

    Dr. Donnenfeld was a Phase-III investigator for Xibrom, and he presented results of two Phase III studies at the ASCRS meeting. The studies evaluated the efficacy and safety of Xibrom compared with placebo dosed twice daily for 14 days after cataract surgery with a 14-day follow-up for safety.

    The study included 527 patients with a summed (cells + flare) ocular inflammation score of more than three following cataract surgery, in the absence of any anti-inflammatory medication. These patients were randomly assigned to bromfenac or placebo. Treatment was initiated 16 to 32 hours after surgery, and patients were assessed on days three, eight, 15, 22 and 29 after surgery. Ocular and systemic safety was assessed throughout the study.

    Of the 527 study participants, 356 were treated with bromfenac, and 171 received placebo. Bromfenac was effective within three days of surgery. In the bromfenac group, 8.4 percent of patients had a summed ocular inflammation score of 0 on day three compared with 1.2 percent of patients in the placebo group. This difference was statistically significant. The proportion of bromfenac subjects with a summed ocular inflammation score of 0 increased at each visit and remained statistically significant through day 29.

    According to the study results, 52 percent of patients who received bromfenac had an anterior chamber cell score of 0 on day eight, compared with 30 percent of patients given placebo. On day 15, 76 percent of bromfenac patients achieved this score, compared to 42 percent of placebo patients.

    In terms of reduction of post-surgical inflammation, 85 percent of bromfenac patients had marked reduction by day 15 compared to 53 percent of patients given placebo. Additionally, placebo patients had more ocular adverse events.

    “We found that Xibrom significantly decreased inflammation at three days, one week, and two weeks after surgery,” he adds.

    Xibrom has been approved for twice-daily dosing, and Dr. Donnenfeld believes that this will improve patient compliance. “A topical NSAID with a twice-daily dosing regimen has the potential to enhance treatment compliance while maintaining clinical efficacy,” Dr. Donnenfeld says. “The twice-daily regimen will reduce the frequency of drug exposure and exposure to preservative.”

    According to Timothy R. McNamara, PharmD, Xibrom has been approved for twice-daily dosing because of its potency.

    “It is a more potent COX-2 inhibitor than other NSAIDs, and very little sting or discomfort is associated with its administration,” he says. Dr. McNamara is director of medical affairs at Ista Pharmaceuticals, Irvine, Calif.

    He emphasizes that the FDA required a more stringent endpoint of using a sum score of zero for cells and flare as the primary endpoint in the Phase III studies, and he notes that the researchers achieved that endpoint to a statistically significant level by the 14th day of therapy.

    Drs. Donnenfeld and McNamara say that more Xibrom studies will be conducted. Xibrom has not been compared to Voltaren and Acular in the United States, and it has not been studied in refractive surgery patients in the United States.

    Xibrom has been used in Japan since 2000, however, and Dr. Donnenfeld says that it has been used in refractive surgery patients there. Dr. McNamara notes that more than 2.7 million patients have received Xibrom in Japan and that it has been compared to other NSAIDs on the market in Japan. “Researchers there have found that it is a much more potent inhibitor of both COX-1 and COX-2, especially COX-2, when compared to diclofenac,” Dr. McNamara says.

    Dr. Perry notes that it is twice as potent as Voltaren for inhibiting COX-1 and almost four times as potent for inhibiting COX-2, and COX-2 is the more important enzyme in terms of inhibiting prostaglandin formation.

    Addressing Safety Concerns

    Some surgeons have questioned the safety of using Xibrom in cataract surgery patients. The oral version of bromfenac sodium was approved by the FDA in 1997, but was voluntarily withdrawn from the United States market approximately a year later following reports of hepatic toxicity when the drug was taken for periods of time exceeding the dosing maximum of 10 days.

    However, according to Dr. Donnenfeld, “clinical data from Japan demonstrated that topically administered bromfenac ophthalmic solution 0.9% did not produce plasma concentrations of bromfenac that would be quantifiable using immunofluorescent assay methods with a sensitivity of 50 nanograms/ml. So, the hepatic toxicity potential for topical bromfenac at the doses and duration of therapy for the treatment of post-cataract surgery ocular inflammation is negligible.”

     

     
    Illuminating Facts About Laser Pointers PDF Print E-mail

    As posted in FDA Consumer magazine and obtained from http://www.fda.gov/fdac/features/2005/305_laser.html

    May/June 2005

    Issue By Linda Bren

    Instructors use them to draw attention to information on slide shows. Astronomers use them to point out stars, planets, and other heavenly bodies. And construction workers use them to level and align pipes.

    These are all legitimate uses of laser pointers, says the Food and Drug Administration, which regulates lasers and other radiation-emitting devices. But the agency is concerned about the misuse of these potentially dangerous devices and their increased availability for purchase on the Internet.

    Laser pointers are misused when they are directed at people or treated as toys. The light energy from a laser pointer aimed into the eye can be more damaging than staring directly into the sun. And the startling effect of a bright beam of light can cause serious accidents when aimed at a driver in a car, a pilot in a plane, or even a person holding a cup of hot coffee. According to the Laser Institute of America, one woman reported how other mothers she knew bought laser pointers for their children so they could imitate Star Wars characters Luke Skywalker and Darth Vader.

    "Laser pointers have become consumer novelty products and promoted as toys," says Jerome Dennis, a consumer safety officer for the FDA's Center for Devices and Radiological Health (CDRH). "They're hazardous as toys and shouldn't be used frivolously.

    "The agency is concerned about the increased availability through the Internet of a variety of laser products that may be illegal or unsafe. Some laser products are intended for use only by professionals or other trained operators. And green laser pointers have the agency particularly concerned. While there are legitimate uses for these green pointers, they may be altered to become more powerful and unsafe if not used responsibly.

    "These overpowered pointers may have been modified to emit more radiation than the manufacturer's original product," says Lt. Cmdr. Sean Boyd, M.P.H., head of the electronic products branch in CDRH, "and they are not compliant with our standard." The FDA sets safety standards that must be met before laser products, including pointers, can be legally sold in the U.S. market.

    "The potential for injury increases as you increase the power output of the product," adds Boyd. "Certainly the potential for distraction or flash blindness or startling increases as well when you're talking about an overpowered green pointer.

    "Flash blindness is a temporary loss of vision that occurs when the eye is suddenly exposed to intense light--even from an unintentional sweep of laser light across a person's eyes. The effect can last from several seconds to several minutes. Recent reports of flash blindness in pilots from laser lights beamed at aircraft have further heightened the agency's concerns.

    The FDA is working to identify manufacturers of overpowered green laser pointers and other illegal laser products and will take action to prevent these unsafe products from being sold in the United States.

    FDA's Authority

    The FDA has the authority to regulate all kinds of lasers. Under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, the agency regulates lasers used in medicine. And under the Electronic Product Radiation Control Provisions of the act, the FDA regulates both medical and nonmedical lasers such as those used to solder circuits in factories, to scan groceries in a supermarket, or to entertain a crowd with a light show in the night sky.

    The FDA may inspect manufacturers of laser products and require the recall of products that don't comply with federal standards or that have radiation safety defects. The agency also may test laser products and inspect displays of laser light shows to ensure the public is protected. Producers of laser light shows are required to tell the FDA where they are planning a display so that the agency can inspect it if possible and take action if required. In 1995, the FDA, working with the Federal Aviation Administration, issued a moratorium that remains in effect on outdoor laser light shows in and near Las Vegas. The action, which affects Clark County, Nev., was taken after airline pilots reported experiencing temporary visual impairment during flights into or out of the county's three airports.

    The FDA requires that labeling on most laser products contain a warning about radiation and other hazards and a statement certifying that the laser complies with FDA safety regulations. The label must also state the power output and the hazard class of the product.

    The FDA recognizes four major hazard classes (I to IV), including two subclasses (IIIa and IIIb), of lasers--ranging from those that pose no known hazard to those that pose serious danger if used improperly. The higher the class, the more powerful the laser. Class I laser products, for example, include laser printers and CD players, which are not considered hazardous because the laser radiation is contained within the product.

    Class IIIb and class IV laser products are very powerful and permit ready access to the laser radiation, which can cause eye or skin injury. Research and industrial lasers and laser light show projectors fall into these classes. Class IIIb and class IV laser light show projectors may be sold only by or to individuals or firms that have obtained approval from the FDA.

    Buyer Beware

    In addition to potentially harming your health, some high-powered pointers can damage your wallet, says Dennis. Consumers who purchase an illegal laser product on the Internet--whether knowingly or unknowingly--may lose their money if the product is manufactured outside the United States, he says. "There is a reasonable risk of having a charge laid against your credit card for goods you're not going to receive because they're going to be blocked by U.S. Customs and Border Protection."

    What Consumers Can Do

    1. Never aim or shine a laser pointer at anyone.

    2. Don't buy laser pointers for your children.

    3. Before purchasing a laser pointer, make sure it has the following information on the label:

    o a statement that it complies with Chapter 21 CFR (the Code of Federal Regulations)

    o the manufacturer or distributor's name and the date of manufacture

    o a warning to avoid exposure to laser radiation

    o the class designation, ranging from Class I to IIIa. Class IIIb and IV products should be used only by individuals with proper training and in applications where there is a legitimate need for these high-powered products.

    For More Information

    If you have questions about a laser product you are considering purchasing or offering for sale on the Internet, contact the FDA's Center for Devices and Radiological Health at (240) 276-0326.

    To report Web sites that you suspect are illegally selling laser products, follow the instructions at www.fda.gov/oc/buyonline/buyonlineform.htm

    See additional information about buying regulated products online at www.fda.gov/oc/buyonline/