Paragon CRT

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1. 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.

2. 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 diopters) and moderate astigmatism. During the U.S. clinical study 121 subjects of the 205 enrolled completed nine months of lens wear.

3. 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.

4. 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). 67% Of the subjects obtained 20/20 vision in at least one eye (their better seeing eye) and 94% achieved 20/40.

5. 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.

6. Is Corneal Refractive Therapy permanent?

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.

7. 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.

8. 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.

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.

9. What do I do in the period of time between when I start Paragon CRT® and when I achieve treatment?

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.

10. 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.

11. Who should not wear Paragon CRT®?

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.