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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06487897

Public ClinicalTrials.gov record NCT06487897. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 5:21 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase III Presbyopia Correction Using the VIS Optimal Keratoplasty (Opti-K™) System (Phase IIIa)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06487897
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
VIS, Inc.
Industry
Enrollment
75 participants

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range
40 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 29, 2024
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027
Last update posted
Sep 4, 2024

2024 – 2027

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
Cohen Laser & Vision Center Boca Raton Florida 33431 Recruiting
Claris Vision Eye Health South Dartmouth Massachusetts 02747 Recruiting
The Cornea & Laser Eye Institute Teaneck New Jersey 07666 Recruiting
OCLI Vision - Oceanside Oceanside New York 11572 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06487897, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 4, 2024 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06487897 live on ClinicalTrials.gov.

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