Phase III Presbyopia Correction Using the VIS Opti-K™ System

Exclusion Criteria

• •1. Latent hyperopia 1.0 D (i.e., baseline MRSE and CRSE should not differ by or be more than 1.0 D or CRSE).
• •2. Nystagmus.
• •3. Significant conjunctivochalasis defined as laxity and/or looseness of the conjunctiva when traction is applied and/or redundancy in its normal state. If there is no redundancy of the conjunctiva under normal conditions, there should be no more than 3 mm of conjunctival movement on the bulbar surface in the cardinal fields of gaze and/or by displacement for the patient to qualify for enrollment.
• •4. Any active ocular surface disease of any severity.
• •5. Any condition causing a cloudy cornea (e.g., scarring, dystrophies, epithelial or stromal edema) or cloudy anterior chamber.
• •6. Allergy to anesthetics or post-treatment medications, including NSAIDS.
• •7. History or current evidence of chronic allergic reactions, tearing and/or ocular irritation that might confound the outcome or increase the risk of the study.
• •8. The use of systemic medications that may confound the outcome or increase the risk of the study, including, but not limited to corticosteroids, antimetabolites, amiodarone, chloroquine, isotretinoin, sumatriptan, or other medications that may affect healing.
• •9. Subjects with a recent history (within one week prior to treatment) of using topical ophthalmic medications containing preservatives (such as benzalkonium chloride, except for medications specifically required in this protocol) and/or other ocular drugs that are cytotoxic.
• •10. Those with ocular manifestations of acute or chronic illness that might increase the risk or confound the outcome of the study (e.g., diagnosed autoimmune disease, systemic connective tissue disease, clinically significant atopic disease, unstable diabetes mellitus and all diabetes with ocular involvement, etc.).
• •11. Pregnant, planning to become pregnant, or lactating women.
• •12. Subjects participating in other ophthalmic clinical trials during this clinical investigation.
• •13. Persons who, in the determination of the investigator, are not competent to understand the procedure or the actions asked of them as research subjects or have unrealistic expectations or are considered emotionally labile.
• •14. Persons who may not be able to complete the requirements of returning to the investigator's clinic over the period of the study, or who may be difficult to locate or contact on short notice. This does not preclude vacations or travel.
• •15. Subjects who are likely to be exposed to high levels of ultraviolet radiation (from sunlight, tanning lights, etc.) without protective eyewear during the one- year period following Opti-K™ treatment.
• •16. Presence or history of any other condition or finding that, in the opinion of the investigator, makes the subject unsuitable as a candidate for Opti-K™ treatment or study participation or may confound the outcome of the study.
• •17. Presence of a pupil irregularity (e.g., decentered pupil or irregular shape) in the eye to be treated that could predispose the eye to a centration error during the treatment.
• •18. Previous intraocular or corneal surgery of any kind in either eye, including any type of surgery for either refractive or therapeutic purposes.
• •19. Subjects using topical ophthalmic medications to treat presbyopia or plan to use these medications during the study follow-up period.