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

Study acronym: Opti-K™
StatusRecruiting
PhasePhase 3
SponsorVIS, Inc.
Started
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Record History

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  1. Start date: Jul 2024 to Sep 30, 2024
    • Primary completion date: Jul 2026 to Dec 2026
    • Study completion date: Jul 2026 to Dec 2027
    • Collaborators shortened, about 5 words
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Interventions: Optimal laser keratoplasty treatment is applied to subject's eye and takes about 1 to 1.5 minutes for a single eye treatment (Device) to Optimal laser keratoplasty (Device)
    • Site details revised at 4 of 4 sites
    • Eligibility criteria shortened, about 4 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
VIS, Inc.
4 trials monitored
See all monitored trials
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.
Trial Details
NCT Number NCT06487897
Lead Sponsor VIS, Inc.
Conditions
(from sponsor)		 Presbyopia
Related terms Myopia, Presbyopia
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov