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Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
Recruiting
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
Who can join
Ages 45 and older · All sexes
Full eligibility criteria
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
About the study
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
What is being tested
- VisiPlate Glaucoma Implant (device)
Sponsor: Avisi Technologies Inc. · Participants: 165 · Started: Nov 7, 2025
Contact the study team
- Katherine Lee · Phone: 12816100251
Official record on ClinicalTrials.gov — NCT07220876
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.