Avisi Technologies Inc.
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
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.
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…
Implant (micro-shunt) for glaucoma patients