Recruiting
Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
ClinicalTrials.gov IDNCT07220876
PhaseNA
Enrollment165
SponsorAvisi Technologies Inc.
Age45 Years
SexALL
Conditions studied
Open Angle Glaucoma (OAG)
About this study
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Interventions
- Device: VisiPlate Glaucoma Implant — Implant (micro-shunt) for glaucoma patients
Primary outcomes
- Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure (12 Months)
Eligibility information
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
Study 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
Showing 10 of 12 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.