Phase III Study of VIS Opti-K System for Presbyopia Correction by Treating the Non-Dominant Eye

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the VIS Opti-K System in improving near vision temporarily by treating the non-dominant eye of adults with presbyopia who have low myopia, emmetropia, or low hyperopia. The study focuses on measuring uncorrected near visual acuity at 40cm and patients subjective satisfaction with their vision. It is a Phase III clinical trial led by VIS, Inc., targeting adults aged 40 years and older. Participants who agree to monovision will receive a single treatment using the VIS Optimal Keratoplasty Opti-K System on their non-dominant eye. The other eye will not receive treatment during this pivotal study. Eligible subjects may undergo one retreatment if necessary to assess the devices impact on near vision. During the trial, participants will attend follow-up visits where their near visual acuity and binocular vision will be measured at three months after treatment. They will also complete satisfaction questionnaires to report their experience. The study monitors visual outcomes and safety over the follow-up period, with participation lasting at least three months after the initial treatment.

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