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NCT06487897 · ClinicalTrials.gov registry record · Phase 3
Phase III Presbyopia Correction Using the VIS Opti-K™ System
A Phase 3 study of Presbyopia, sponsored by VIS.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
- 4
- Study locations
NCT06487897: Recruiting Phase 3 study of Presbyopia, sponsored by VIS.
NCT06487897 is a Phase 3 study of Presbyopia that is actively recruiting participants, run by VIS. The registered enrollment target is 75 participants, below the 269-participant average among 38 other Presbyopia trials with a reported enrollment target (72% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06487897, a Phase 3 study of Presbyopia, is actively recruiting participants, sponsored by VIS.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
• The proportion of treated eyes (target: at least 50%) that achieve an uncorrected near visual acuity (UNVA) that is 2 or more lines better than Screening following treatment
Conditions Studied
Interventions
- DEVICE Optimal laser keratoplasty
Study Locations (4)
Florida
- Cohen Laser & Vision Center - Boca Raton
Massachusetts
- Claris Vision Eye Health - South Dartmouth
New Jersey
- The Cornea & Laser Eye Institute - Teaneck
New York
- OCLI Vision - Oceanside - Oceanside
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2024-09-30 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
What NCT06487897 shows while recruiting
NCT06487897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 269-participant average among 38 other Presbyopia trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Presbyopia appearing as the primary indexed condition, and to 1 intervention - of which Optimal laser keratoplasty is the first listed.
NCT06487897 reports a single indexed study location in Florida, Massachusetts, New Jersey.
Frequently Asked Questions
What is clinical trial NCT06487897 about?
NCT06487897 is a clinical study titled "Phase III Presbyopia Correction Using the VIS Opti-K™ System". 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 question...
What is the current status of trial NCT06487897?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2024-09-30. Estimated completion is 2027-12.
What conditions does trial NCT06487897 study?
This clinical trial studies the following conditions: Presbyopia.
What interventions are being tested in trial NCT06487897?
The interventions under investigation include: Optimal laser keratoplasty (DEVICE).
Who is sponsoring clinical trial NCT06487897?
This trial is sponsored by VIS, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06487897 being conducted?
This trial has 4 study locations across Florida, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Presbyopia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06487897's enrollment target sits among peer trials
75 19th of 38 higher than 19 of 38 other Presbyopia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Presbyopia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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