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.
Alternatives To Refractive Surgery & Intacs PDF Print E-mail
Friday, 16 May 2008 16:06

Paragon CRT®

paragon

No Glasses... No Daytime Contacts... No Surgery!

Paragon Vision Sciences is the manufacturer of Paragon CRT®, a unique rigid gas permeable contact lens designed to temporarily correct myopia (nearsightedness) by gently and reversibly reshaping your cornea while you sleep. Paragon CRT lenses are made from an overnight contact lens material in a special design intended for this purpose.

According to Paragon, Corneal Refractive Therapy is a non-invasive (non-surgical) alternative to Refractive surgery, developed to reshape the cornea while you sleep. This allows you to go throughout the day without any lenses, and without expensive surgery!

"Recent clinical research combined with the latest corneal surface mapping technology, computerized manufacturing and space age oxygen-breathing materials have brought new science to corneal reshaping", states Paragon's website.

Paragon CRT® Inquiries Increase With Recent FDA Hearing on LASIK

Mesa, AZ (Apr 29, 2008) Paragon Vision Sciences, the manufacture of Paragon CRT® for overnight corneal reshaping to temporarily correct nearsightedness, commented today that inquiries have increased by doctors, consumers and distributors worldwide for its non-surgical contact lens. Paragon CRT provides similar visual benefits as LASIK so that patients can go all day long without their glasses or daytime contacts, however, it also provides other significant benefits for both children and adults in that it’s temporary and reversible. These dramatic rise in inquiries is coming quickly on the heels of a Nationwide consumer alert that the FDA convened a special meeting on Friday, April 25, to hear from LASIK surgeons, as well as, disgruntled patients who say their eyesight has been irreparably damaged by the surgery.

Joe Sicari, President of Paragon Vision Sciences, commented;

"While LASIK has improved the lives of so many people, it is unfortunate that of the estimated 7.6 million Americans who have undergone some sort of laser vision correction that approximately 400,000 have experienced unacceptable outcomes. In some cases this may include permanent vision impairment. We are pleased that Paragon CRT offers a non-surgical and reversible alternative for the freedom from glasses and traditional contact lenses that consumers seek. It is my hope that the Myopia Control research, currently underway with CRT and providing very promising early results, will enable us to nonsurgically halt the progression of nearsightedness. We are also observing expanding indications that CRT is emerging as an answer to dry eye discomfort among soft lens wearers since CRT lenses are not worn during functioning hours providing maximum visual comfort. I would like to think doctors who advise patients against LASIK would consider CRT as an alternative method to vision correction."

While LASIK is a good procedure for many people, most consumers fear eye surgery. After all no one wants surgery. What consumers really desire is the freedom from their glasses and traditional contact lenses. In June 2002, Paragon CRT (Corneal Refractive Therapy) was FDA approved for all ages. CRT allows the consumer to wear a special contact lens ONLY DURING SLEEPING HOURS. Upon awakening, the lenses are removed providing 20/20 vision for one to three days. No Surgery. No Daytime Contacts. No Glasses.

CRT lenses are also used by some surgeons to correct unacceptable visual outcomes following LASIK. The lenses can adjust for small over and under corrections. It is generally accepted by those surgeons that CRT is safer than additional surgery. LASIK surgeons should inform people interested in LASIK about this non-invasive and temporary alternative but, generally, do not. The reasons are varied.

An estimated 4,000 practitioners in the USA already fit CRT lenses and there are well over 200,000 very happy consumers including adults and children.

Paragon Vision Sciences has a history of innovation that spans four (4) decades with many “First” achievements in the contact lens industry including; the First to gain FDA approval for overnight corneal reshaping for myopia with and without astigmatism, the First to secure FDA approval for Plasma treatment of Paragon GP materials and the First to collaborate with NASA to conduct research on gas permeable materials aboard three space shuttle missions spanning almost 10 years. As a result, Paragon’s HDS® technology with the hyper-purified delivery system was used to launch the market leading HDS® and HDS® 100 high oxygen permeable materials that are so widely prescribed today.

Paragon Vision Sciences is a privately held, specialty vision research, development and products company, located near Phoenix in Mesa, Arizona, owned and operated by Joe Sicari, President & CEO and members of his management team. Paragon is the manufacturer of world-renowned oxygen permeable contact lens materials including Paragon HDS®, Paragon HDS® 100, Paragon Thin, FluoroPerm®, and Paraperm® family of materials for a wide range of indications.

For more information about Paragon Vision Sciences GP materials or Paragon CRT® call 800.528.8279.

Data on file – Paragon Vision Sciences - 2008

Paragon CRT® lenses are available throughout North America and are also available Internationally! Please visit Paragon's WEBSITE for this and other information.

The information contained on these pages are not intended to supplant medical advice. As all eyes are different, These lenses may NOT be for you! Please consult your ophthalmologist to see if they are. I've included Paragon's FAQ's below.

 


What is Paragon CRT®?

Paragon CRT is a specially designed oxygen permeable therapeutic contact lens used in Corneal Refractive Therapy.  Corneal Refractive Therapy is a sophisticated, non-surgical process, which reshapes the cornea while you sleep.  You remove the lenses when you awake and are able to go throughout the day without any other correction.

How new is Paragon CRT?

Contact lens corneal reshaping is not a new concept.  Previous corneal reshaping designs were only as successful as technology allowed.  Paragon Vision Sciences has taken the recent advancements in computerized corneal mapping, computerized manufacturing, and oxygen permeable contact lens materials and produced a therapeutic contact lens design that is like no other.  This has allowed Paragon CRT to become the one corneal reshaping modality that truly stands out and the first to earn FDA approval for nighttime Corneal Refractive Therapy. 

Is Corneal Refractive Therapy Permanent?

No. It’s temporary.  If you stop wearing the lenses regularly while you sleep, your vision will return to its original state in as little as 72 hours.

Can everyone wear Paragon CRT?

Not everyone can wear Paragon CRT.  This lens is designed for individuals with low to moderate myopia (nearsightedness up to –6.00 diopters) with or without astigmatism (up to –1.75 diopters).  Paragon CRT therapeutic lenses are not yet available in bifocal prescriptions for presbyopia (which requires reading glasses or bifocals).  At your doctor’s discretion you may be fitted in a monovision mode (one eye corrected for near vision and one corrected for distance vision).  You might still need reading glasses.  However, since there are variations in patient physiology and visual needs, the decision for CRT, at any age, can only be made after a thorough eye exam and the recommendations of the eye care professional.  At this time, hyperopia (farsightedness) is not correctable with CRT.

How long does it take to reach good vision?

Most patients have rapid improvement in the first few days of treatment and achieve nearly their optimum vision in 10 to 14 days.

What do I do to see adequately in the period of time between when I start Corneal Refractive Therapy with Paragon CRT and when I achieve full treatment?

It’s important to understand that for a time after you have begun treatment, but before sufficient treatment is realized, your old glasses or contacts will no longer be the appropriate prescription.  It may involve insertion of your Paragon CRT lenses for part of the day or some use of temporary soft lenses in different prescriptions as an option. Your eye care practitioner will discuss your options for visual correction during that transitional period of time.

Are there any risks involved with wearing Paragon CRT?

There is a small risk involved when any contact lens is worn.  It is not expected that the Paragon CRT lenses for contact lens Corneal Refractive Therapy will provide a risk that is greater than other contact lenses.  There were no serious adverse events reported in the Paragon CRT FDA clinical study.

Can I see with my Paragon CRT lenses in?

Yes.  One of the great features of the Paragon CRT lens is that if you have to get up in the middle of the night, you will be able to see where you are going.  Or, if during the initial treatment phase, you find you need some form of vision correction, you can put in your Paragon CRT lenses and see clearly.

How often will I have to replace my Paragon CRT lenses?

Generally speaking the Paragon CRT lenses will have to be replaced once a year.  However, depending on factors such as protein build-up, how well the lenses are taken care of, etc., the lenses may have to be replaced more frequently.

How do I care for my Paragon CRT lenses?

Your lenses should be chemically disinfected after every use (not heat).  Your eye care practitioner will instruct you about which care system is best for you.

How much does Corneal Refractive Therapy with Paragon CRT cost?

The cost for your initial fitting, professional care, follow-up and Paragon CRT therapeutic lenses varies by practitioner.  After your first year, the annual cost of CRT is about the same as wearing contact lenses or glasses.  Many eye care Practitioners also offer optional payment plans, which they will be happy to review with you.  Consult your Paragon CRT eye care practitioner for further specific information.  You may also consult want to consult with your employer about Flexible Spending Accounts.

A Flexible Spending Account (FSA), (also called flex plan, reimbursement account, Flex 125, Tax Saving Plan, Medical Spending Account, a Section 125, or a Cafeteria Plan), is an employer-sponsored benefit that allows you to pay for eligible medical expenses on a pre-tax basis (there are also similar accounts for dependent and child-care expenses). If you expect to incur medical expenses that won't be reimbursed by your regular health insurance plan, you should be taking advantage of your employer's FSA if they have one.

Any expense that is considered a deductible medical expense by the IRS and is not reimbursed through your insurance can be reimbursed through the FSA. These include most elective surgery, corneal refractive therapy, laser vision correction, deductibles, eyeglasses, and prescription drug co-payments.

Not all employers participate in FSA programs. It is recommended you check with your Benefits Manager to see if your employer participates. It is important to calculate how much money to contribute for the year. If you put in more money than you need, by law, you lose it. For Corneal Refractive Therapy, it’s recommend you have a consultation first to determine candidacy prior to making any allocations to your Flexible Spending Account.

Is Corneal Refractive Therapy painful?

The therapy is not painful.  Initially, you may have a slight awareness of the therapeutic lens.  You will not feel the lenses when you sleep and there is no sense of physical corneal change…. just visual improvement when the lenses are removed.

Is Corneal Refractive Therapy or Paragon CRT FDA approved?

Paragon CRT is the first therapeutic lens design approved by the FDA for overnight contact lens Corneal Refractive Therapy for the temporary reduction of myopia.  Paragon Vision Sciences, the manufacturer of Paragon CRT, received the final written approval on June 13, 2002.  The issuance of this approval is the culmination of the most extensive clinical study to date to establish the safety and efficacy of contact lens corneal reshaping in overnight use.

What is the difference between Corneal Refractive Therapy and Paragon CRT?

Corneal Refractive Therapy is the process of using a therapeutic contact lens to reduce myopia by reshaping the corneal surface while you sleep.  Paragon CRT is the product for this therapy.

Are there age restrictions for Corneal Refractive Therapy with Paragon CRT?

No.  The FDA placed no age restrictions on candidates for Corneal Refractive Therapy with Paragon CRT.   CRT is being successfully performed on children 12 years old and younger.  It can be a great option for children and teens that are active in sports activities or any other extra curricular activities.

Those who are older and presbyopic (requiring reading glasses or bifocals) may still be candidates for CRT.  They may correct their distance vision with CRT and wear near-vision reading glasses for close work.  At the doctor’s discretion you may be fitted in a monovision mode (one eye corrected for near vision and one corrected for distance vision). 

Visual requirements due to age or activities can only be assessed after a thorough eye exam.  Your Paragon CRT certified eye care professional will recommend what is best for you.

Are the Paragon CRT lenses difficult to insert or remove?

These lenses are generally no more difficult to insert or remove than any other similar contact lens.  You may want to instill comfort or rewetting drops prior to insertion of the lenses and immediately upon waking.  The lenses must move freely prior to removal.  If you have difficulty removing the Paragon CRT lens, there are lens removal aids available to assist this process.

If I discontinue CRT, will my vision to return to normal?

There are no recorded permanent corneal changes post-treatment.  Generally, the more myopia being reduced, the longer it will take for the corneal curvature to return to normal.  For instance, if your pretreated correction was - 4.50D, it would take a few days longer to return to normal than if the pretreated correction was -1.50D. 

My driver’s license is marked that I need corrective lenses to operate a motor vehicle.  What do I do about that?

Your eye care professional will supply you with a document that states you are participating in a visual therapy program that eliminates the need for corrective lenses during working hours.  The document should have an expiration date and you should have your driver’s license updated with a new vision screening through your local DMV office to reflect this change, before the expiration date.

What happens if I lose or damage a lens?

Corneal Refractive Therapy is different than wearing regular contact lenses.  If you discontinue wear for one night, your vision may be impaired the next day.  Previously worn glasses or contact lenses may not help.  Immediate replacement is necessary!  Having a spare pair of lenses is strongly recommended.

Do benefit programs cover Corneal Refractive Therapy?

This is an elective procedure, and to the best of our knowledge is not usually covered by benefit programs.  If regular contact lenses are covered under your vision care plan, Corneal Refractive Therapy may be partially covered.  You should check with your benefits plan administrator. 

I suffer from “dry” eyes, am I a candidate for Corneal Refractive Therapy?

Only your eye care professional can determine if you are a CRT candidate.  Many patients with slightly dry eyes do well with CRT.  Since you are wearing the lenses only while sleeping, the closed eye state minimizes evaporative loss of tears and can give dry-eye patients suitable vision without compromising the ocular surface.

I used to wear contact lenses, but stopped due to discomfort.  Am I a candidate for Corneal Refractive Therapy?

Paragon CRT lenses are worn at night while you are sleeping.  This greatly reduces any discomfort normally experienced while wearing contact lenses during the day. 

I have astigmatism.  Am I a candidate for Corneal Refractive Therapy?

Paragon CRT is designed to correct myopia with to 1.75 diopters of astigmatism.  Each individual should be evaluated by a certified eye care professional to determine if CRT is right for your visual requirements.

I wear glasses.  Am I a candidate for Corneal Refractive Therapy?

The transition from wearing only glasses to Paragon CRT should not be a concern.  About 18% of the patients in the FDA study were non-contact lens wearers.   The dropout rate related to discomfort was only 3.9%.

How can I tell if I have the original Paragon CRT lenses?

Each lens is laser marked to assure you and your eye care practitioner that you have the original Paragon CRT therapeutic contact lens.