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NCT07220876NARecruiting

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

Avisi Technologies Inc.

Start Date

11/7/2025

Completion Date

10/1/2027

Summary

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

Detailed Description

To evaluate the safety and effectiveness of VisiPlate Aqueous Shunt to lower intraocular pressure (IOP) in subjects with open-angle glaucoma for whom medical and surgical treatments have failed.

Eligibility Criteria

Age Range: 45 years to No maximum

Inclusion Criteria: * Open angle, pseudoexfoliative or pigmentary glaucoma * IOP at preoperative visit of ≥ 20mmHg and ≤ 40mmHg * Visual field mean deviation score of -3dB or worse * Area of healthy, free and mobile conjunctiva in the target quadrant * Shaffer angle grade ≥ 2 in the target quadrant Exclusion Criteria: * Angle closure glaucoma * Congenital, neovascular or other secondary glaucomas * Previous intraocular surgery, with the exception of uncomplicated cataract surgery * Previous glaucoma shunt/valve in the target quadrant * Clinically significant inflammation or infection in the study eye within 30 days prior to the operative visit * History of corneal surgery, corneal opacities or corneal disease * Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition

Interventions

DEVICE

VisiPlate Glaucoma Implant

Interested in This Trial?

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Conditions

Open Angle Glaucoma (OAG)

Locations

Arizona Advanced Eye Research

Glendale, Arizona 85306

United States

Sacramento Eye Consultants

Sacramento, California 95815

United States

ICON Eye Care

Grand Junction, Colorado 81501

United States

Mile High Eye Institute

Sheridan, Colorado 80226

United States

Cleveland Clinic- Cole Eye Institute

Cleveland, Ohio 44195

United States

Scheie Eye Institute

Philadelphia, Pennsylvania 19104

United States

Wills Eye Hospital

Philadelphia, Pennsylvania 19107

United States

Glaucoma Associates of Texas

Dallas, Texas 75231

United States

University of Texas Southwestern

Dallas, Texas 75390

United States

The Eye Centers of Racine & Kenosha

Kenosha, Wisconsin 53142

United States

Lynette Venter

Bloemfontein, 9301

South Africa

Pretoria Eye Institute

Pretoria, 0007

South Africa