Phase III Presbyopia Correction Using the VIS Optimal Keratoplasty (Opti-K™) System (Phase IIIa)
VIS, Inc.
Summary
The goal of this clinical trial is to evaluate the safety and efficacy of using the VIS Opti-K System to enable monovision by providing temporary improvement in near vision through the treatment of the non-dominant eye of low myopic, emmetropic and low hyperopic presbyope subjects. The main questions it aims to answer are determining uncorrected near visual acuity at 40cm in the treated eye and subjective improvement as measured by the patient satisfaction questionnaire.
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
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 D and +0.25 D with no more than 0.75 D of refractive cylinder needing +1.00 D to +2.50 D 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) in both eyes. 5. Best correcte…
Interventions
- DeviceOptimal laser keratoplasty
Laser
Locations (4)
- Cohen Laser & Vision CenterBoca Raton, Florida
- Claris Vision Eye HealthSouth Dartmouth, Massachusetts
- The Cornea & Laser Eye InstituteTeaneck, New Jersey
- OCLI Vision - OceansideOceanside, New York