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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 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.

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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.

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

FieldValue
Enrollment Target 75 participants
Start Date 2024-09-30
Est. Completion 2027-12
Phase Phase 3

Sponsor

VIS

2 total trials

What the Registry Record Tells You About NCT06487897

The ClinicalTrials.gov registry entry for NCT06487897 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 269-participant average among 38 other Presbyopia trials with a reported enrollment target (72% lower). The listed sponsor is VIS, which has 2 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.