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

NCT06487897 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-09-05

No results posted yet for this 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

Interventions

DEVICE

Optimal laser keratoplasty

Laser

Sponsors & Collaborators

  • VIS, Inc.

    lead INDUSTRY

Principal Investigators

  • Harry Glen, M.D.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06487897 on ClinicalTrials.gov