Phase III Presbyopia Correction Using the VIS Optimal Keratoplasty (Opti-K™) System (Phase IIIa)
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.
• Subject age is equal to or greater than 40 years old.
• 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.
• 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.
• Uncorrected distance visual acuity (UDVA) 20/25 or better (i.e., LogMAR ≤ 0.10) in both eyes.
• Best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.
• Uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR \< 0.70) in the non-dominant eye.
• Best corrected near visual acuity (CNVA) of at least 20/20 in both eyes (LogMAR ≤ 0.00).
• Subject has normal corneal topography.
• Subject must have documented monovision tolerance (per Appendix B)
⁃ Subject is not a contact lens wearer or, if wearing contact lenses, has discontinued wearing contact lenses for the required period of time and completed the contact lens stability check as described below.
⁃ a. Contact Lens Wearers Only: Demonstration of a stable refraction, defined as two manifest refractions that are within ± 0.5 D MRSE of each other as determined under the following conditions: i. The two refractions are performed at least 7 days apart; and, ii. Contact lenses are not worn for at least the specified period prior to 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 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks
⁃ Subject is willing and able to comply with all pre-treatment and follow-up requirements, including the ability to read English to complete the PROWL questionnaire
⁃ Subject understands the nature of the procedure, as well as potential risks or limitations of the treatment, and provides informed consent.
⁃ Subject will make every effort to have no other refractive or ocular surgery during their study post-treatment follow-up period.