RecruitingNot ApplicableNCT07220876

Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma

A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial of the Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma


Sponsor

Avisi Technologies Inc.

Enrollment

165 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial


Eligibility

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and effectiveness of a new drainage device called VisiPlate for treating glaucoma that hasn't responded well to other treatments. The device works like a tiny drain for excess fluid in the eye to reduce pressure. **You may be eligible if...** - You have open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma - Your eye pressure is between 20 and 40 mmHg before surgery - Your visual field test shows significant loss - The target area of your eye has healthy tissue available for the device **You may NOT be eligible if...** - You have angle-closure, neovascular, or congenital glaucoma - You have had previous eye surgery (other than uncomplicated cataract removal) - You already have a glaucoma drain/valve in the target area - You have had significant eye inflammation or infection in the last 30 days - You have corneal disease, retinal disease, or optic nerve disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVisiPlate Glaucoma Implant

Implant (micro-shunt) for glaucoma patients


Locations(12)

Arizona Advanced Eye Research

Glendale, Arizona, United States

Sacramento Eye Consultants

Sacramento, California, United States

ICON Eye Care

Grand Junction, Colorado, United States

Mile High Eye Institute

Sheridan, Colorado, United States

Cleveland Clinic- Cole Eye Institute

Cleveland, Ohio, United States

Scheie Eye Institute

Philadelphia, Pennsylvania, United States

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Glaucoma Associates of Texas

Dallas, Texas, United States

University of Texas Southwestern

Dallas, Texas, United States

The Eye Centers of Racine & Kenosha

Kenosha, Wisconsin, United States

Lynette Venter

Bloemfontein, South Africa

Pretoria Eye Institute

Pretoria, South Africa

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07220876


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