Frequently Asked Questions About Paragon CRT®
- What is Paragon CRT®?
- How new is Paragon CRT?
- Is Corneal Refractive Therapy permanent?
- Can everyone wear Paragon CRT?
- How long does it take to reach good vision?
- What do I do in the period of time between when I start Paragon CRT® and when I achieve treatment?
- What are the risks of wearing Paragon CRT?
- How likely is it that Paragon CRT® will work for me?
- Can I see with my Paragon CRT appliances in?
- How often will I have to replace my Paragon CRT appliances?
- How do I care for my Paragon CRT appliances?
- How much does Corneal Refractive Therapy with Paragon CRT cost?
- Is Corneal Refractive Therapy painful?
- Is Corneal Refractive Therapy or Paragon CRT FDA approved?
- What is the difference between Corneal Refractive Therapy and Paragon CRT?
- What if I have questions about Paragon CRT®?
- Who should not wear Paragon CRT®?
- Are there age restrictions for Corneal Refractive Therapy with Paragon CRT?
- Are the Paragon CRT appliances difficult to insert or remove?
- If I discontinue CRT, will my vision to return to normal?
- My driver’s license is marked that I need corrective lenses to operate a motor vehicle. What do I do about that?
- What happens if I lose or damage a lens?
- Do benefit programs cover Corneal Refractive Therapy?
- I suffer from dry eyes, am I a candidate for Corneal Refractive Therapy?
- I used to wear contact lenses, but stopped due to discomfort. Am I a candidate for Corneal Refractive Therapy?
- I have astigmatism. Am I a candidate for Corneal Refractive Therapy?
- I wear glasses. Am I a candidate for Corneal Refractive Therapy?
- How can I tell if I have the original Paragon CRT appliances?
- What are some important things for me to remember.
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 appliances are made from an overnight contact lens material in a special design intended for this purpose.
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 night-time Corneal Refractive Therapy.
No, it is temporary. If you stop wearing the lenses regularly while you sleep your lens-free vision will return to its original state in as little as 72 hours.
Not everyone can wear Paragon CRT. This lens is intended for individuals with low to moderate myopia (nearsightedness up to -6 diopters) and moderate astigmatism. During the U.S. clinical study 121 subjects of the 205 enrolled completed nine months of lens wear.
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.
It is important to understand that for a time after you have begun beginning treatment but before sufficient treatment is realized, your old glasses will no longer be the appropriate prescription. Your eye care professional will discuss what your options are for visual correction during that period of time.
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.
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, orneovascularization, 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.
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). 67% Of the subjects obtained 20/20 vision in at least one eye (their better seeing eye) and 94% achieved 20/40.
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 appliances and see clearly.
Generally speaking the Paragon CRT appliances 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.
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.
The cost for your initial fitting, professional care, follow-up and Paragon CRT therapeutic lenses varies. 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. You should consult your Paragon CRT eye care practitioner for further specific information.
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.
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.
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.
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 appliances, please contact your eye care professional.
Persons who exhibit any of the following conditions should not wear Paragon CRT:
- 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 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.
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.
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.
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.
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.
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
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.
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.
Paragon CRT appliances are worn at night while you are sleeping. This greatly reduces any discomfort normally experienced while wearing contact lenses during the day.
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.
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%.
Each lens is laser marked to assure you and your eye care practitioner that
you have the original Paragon CRT therapeutic contact lens.
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.