A Prospective, Multicenter Clinical Trial to Test the Safety and Effectiveness of the VisiPlate Aqueous Shunt Device in Adults 45 and Older With Refractory Open-Angle Glaucoma

What this Trial Is About

This clinical trial focuses on patients aged 45 and older with refractory open-angle glaucoma, a condition where the pressure inside the eye remains high despite medical and surgical treatments. The study aims to evaluate the safety and effectiveness of the VisiPlate Aqueous Shunt, a device designed to lower intraocular pressure IOP in these patients. This prospective, multicenter, single-arm, open-label trial is sponsored by Avisi Technologies Inc. and seeks to provide new options for those with limited treatment success. Participants will receive the VisiPlate Glaucoma Implant, a micro-shunt device placed in the eye to reduce IOP. This is a single treatment arm study without a comparison group or placebo. The device is implanted to help control eye pressure in patients with specific types of glaucoma, including open-angle, pseudoexfoliative, or pigmentary glaucoma. The study involves monitoring the devices impact on IOP over a 12-month period. Throughout the study, participants will undergo regular evaluations to measure intraocular pressure and assess any changes in their eye health. The primary outcome is the proportion of participants achieving at least a 20% reduction in mean diurnal IOP after 12 months. Secondary outcomes include the percentage change in IOP during this time. Safety and effectiveness will be closely monitored, with follow-up visits to track progress and address any complications. The total duration of participation is at least one year following device implantation.

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