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

Inclusion Criteria:

1. Subject age is equal to or greater than 40 years old.

2. Subjects must have a manifest refraction spherical equivalent (MRSE) between -0.5 Dand +0.25 D with no more than 0.75 D of refractive cylinder needing +1.00 D to +2.50D of reading add in both eyes.

3. Documented stable refractions defined as 0.5 D or less change in MRSE per year for 12 months or longer prior to primary Opti-K™ treatment, based on refractions,medical records, or prescription history.

4. Uncorrected distance visual acuity (UDVA) 20/25 or better (i.e., LogMAR ≤ 0.10) inboth eyes.

5. Best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.

6. Uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR < 0.70) in the non-dominant eye.

7. Best corrected near visual acuity (CNVA) of at least 20/20 in both eyes (LogMAR ≤ 0.00).

8. Subject has normal corneal topography.

9. Subject must have documented monovision tolerance (per Appendix B)

10. Subject is not a contact lens wearer or, if wearing contact lenses, has discontinuedwearing contact lenses for the required period of time and completed the contactlens stability check as described below. a. Contact Lens Wearers Only: Demonstration of a stable refraction, defined as twomanifest refractions that are within ± 0.5 D MRSE of each other as determined underthe following conditions: i. The two refractions are performed at least 7 daysapart; and, ii. Contact lenses are not worn for at least the specified period priorto the first refraction used to establish stability and through the day of surgery: Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 WeekSoft Toric 2 Weeks Rigid gas permeable 2 Weeks

11. Subject is willing and able to comply with all pre-treatment and follow-uprequirements, including the ability to read English to complete the PROWLquestionnaire

12. Subject understands the nature of the procedure, as well as potential risks orlimitations of the treatment, and provides informed consent.

13. Subject will make every effort to have no other refractive or ocular surgery duringtheir study post-treatment follow-up period.

Exclusion Criteria:

1. Latent hyperopia 1.0 D (i.e., baseline MRSE and CRSE should not differ by or be morethan 1.0 D or CRSE).

2. Nystagmus.

3. Significant conjunctivochalasis defined as laxity and/or looseness of theconjunctiva when traction is applied and/or redundancy in its normal state. If thereis no redundancy of the conjunctiva under normal conditions, there should be no morethan 3 mm of conjunctival movement on the bulbar surface in the cardinal fields ofgaze 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 orstromal 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 ocularirritation 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 riskof the study, including, but not limited to corticosteroids, antimetabolites,amiodarone, chloroquine, isotretinoin, sumatriptan, or other medications that mayaffect healing.

9. Subjects with a recent history (within one week prior to treatment) of using topicalophthalmic medications containing preservatives (such as benzalkonium chloride,except for medications specifically required in this protocol) and/or other oculardrugs that are cytotoxic.

10. Those with ocular manifestations of acute or chronic illness that might increase therisk or confound the outcome of the study (e.g., diagnosed autoimmune disease,systemic connective tissue disease, clinically significant atopic disease, unstablediabetes 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 clinicalinvestigation.

13. Persons who, in the determination of the investigator, are not competent tounderstand the procedure or the actions asked of them as research subjects or haveunrealistic expectations or are considered emotionally labile.

14. Persons who may not be able to complete the requirements of returning to theinvestigator's clinic over the period of the study, or who may be difficult tolocate 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 (fromsunlight, tanning lights, etc.) without protective eyewear during the one- yearperiod following Opti-K™ treatment.

16. Presence or history of any other condition or finding that, in the opinion of theinvestigator, makes the subject unsuitable as a candidate for Opti-K™ treatment orstudy participation or may confound the outcome of the study.

17. Presence of a pupil irregularity (e.g., decentered pupil or irregular shape) in theeye to be treated that could predispose the eye to a centration error during thetreatment.

18. Previous intraocular or corneal surgery of any kind in either eye, including anytype of surgery for either refractive or therapeutic purposes.

19. Subjects using topical ophthalmic medications to treat presbyopia or plan to usethese medications during the study follow-up period.