What is Paragon CRT®?

Paragon CRT is a specially designed oxygen permeable therapeutic contact lens used in Corneal Refractive Therapy.

What is Corneal Refractive Therapy?

Corneal Refractive Therapy is a sophisticated non-surgical process that temporarily reshapes the cornea while you sleep. You remove the lenses when you awake and are able to go throughout the day without any other vision correction.

How new is Paragon CRT?

The idea of 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 to produce 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?

Paragon CRT treats nearsightedness (myopia up to –6.00 diopters) with or without minor astigmatism (up to –1.75 diopters). And because there are no age restrictions on Paragon CRT, it may be the perfect option for any member of the family including active adolescents. The doctor will provide more information about Paragon CRT to see if it is right for you. Paragon CRT therapeutic contact lenses are not yet available in bifocal prescriptions for presbyopia (which requires reading glasses or bifocals). 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). You might still need reading glasses. However, since there are variations in patient physiology and visual needs, the decision for Paragon CRT, at any age, can only be made after a thorough eye exam and the recommendations of an eye care professional. At this time, hyperopia (farsightedness) is not correctable with Paragon CRT.

Most Frequently Asked Consumer Questions

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 re-insertion of your Paragon CRT lenses for part of the day or some use of temporary soft lenses in different prescriptions. The doctor will discuss your options for visual correction during that 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 get up in the middle of the night, you will be able to see perfectly. You will enjoy great vision with your Paragon CRT lenses on or off.

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

Generally speaking, the Paragon CRT lenses will have to be replaced annually.However, depending on factors such as protein buildup, how well the lenses are taken care of, etc., the lenses may have to be replaced more or less frequently.

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 used 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. Paragon 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 Paragon CRT. They may correct their distance vision with Paragon CRT and wear near vision 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 made after a thorough eye exam and recommendations of a Paragon CRT certified eye care professional.

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 modality. 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 while operating a motor vehicle. The document should have an expiration date for this treatment 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 Paragon 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 up to 1.75 diopters of astigmatism. Each individual should be evaluated by a certified eye care professional to determine if Paragon 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.

PARAGON CRT® RIGID GAS PERMEABLE CONTACT LENSES FOR OVERNIGHT WEAR

What is Paragon CRT? 

Paragon CRT is a unique rigid gas permeable contact lens designed to temporarily correct myopia (nearsightedness) by gently and reversibly reshaping your cornea while you sleep. You may then be able to go throughout the day without any lenses. Paragon CRT lenses are made from an overnight contact lens material in a special design intended for this purpose.

Can everyone wear Paragon CRT?

Not everyone can wear Paragon CRT. This lens is intended for individuals with low to moderate myopia (nearsightedness up to –6.00 diopters) and moderate astigmatism. During the U.S. clinical study 121 subjects of the 205 enrolled completed nine months of lens wear.

How likely is it that Paragon CRT will work for me?

Of the 159 eyes targeted for 20/20 vision (who had this acuity with their best spectacles), 59% obtained 20/20 or better without other correction and 92% obtained 20/40 or better  at 9 months. (20/40 vision is the acuity required in most states to drive without glasses). Sixty-seven percent of the subjects obtained 20/20 vision in at least one eye (their better seeing eye) and 94% achieved 20/40.

Who should not wear Paragon CRT?

Persons who exhibit any of the following conditions:

• Inflammation or infection of the eye

• Any eye disease, injury, or abnormality that affects the cornea or surrounding tissue

• Any systemic disease that may affect the eye or be worsened by wearing contact lenses

• Allergic reactions of the eye, which may be caused or exaggerated by wearing

• contact lenses or use of contact lens solutions

• Eyes that are red or irritated, or suffer severe dryness

What are the risks of wearing Paragon CRT?

There is a small risk involved when any contact lens is worn. It is not expected that the Paragon CRT Contact Lenses for Corneal Refractive Therapy will provide a risk that is greater than other rigid gas permeable contact lenses. Because this procedure is reversible some patients may notice changes in their vision late in the day.

Basic Information for Patients

What are the risks of wearing Paragon CRT? (con’t)

The two most common side effects that occur in rigid contact lens wearers are corneal edema and corneal staining. It is anticipated that the same side effects will also occur in some wearers of Paragon CRT. Other side effects that sometimes occur in all contact lens wearers are pain, redness, tearing, irritation, discharge, abrasion of the eye or distortion of vision. These are usually temporary conditions if the contact lenses are removed promptly. In very rare instances, infections of the eye, corneal ulcer, iritis, or neovascularization, corneal scarring, permanent decreased vision may occur. The occurrence of these side effects should be minimized or completely eliminated if proper lens care is exercised.

How do I care for my lenses?

Your lenses should be chemically disinfected after every use (not heat). Your eye care practitioner will instruct you about what care system is best for you. Your lenses should be replaced as your eye care practitioner sees fit.

How long does it take to reach good vision?

Most patients have rapid improvement in the first few days of treatment and have achieved nearly their optimum vision in 10 to 14 days. A small percentage of patients will not improve enough to function under all conditions without additional correction.

What are some important things for me to remember?

If you feel like you are having a problem with your vision or contact lenses, immediately remove your lenses and call your eye care professional. Always follow the instructions your eye care professional has given you about lens wear, follow-up and care systems.

What if I have questions about Paragon CRT?

It is essential that you discuss any issues you may have about your eye health or contact lens wear with your eye care professional. If you need any further information about Paragon CRT lenses, please contact your eye care professional.