NCT05557058

GORE Glaucoma Drainage Implant Clinical Study Dominican Republic

A Prospective, Single-Center, Early Feasibility Clinical Study Designed to Evaluate the Safety and Effectiveness of the GORE Glaucoma Drainage Implant (GORE GDI) in Subjects With Primary Open-Angle Glaucoma Uncontrolled by Hypotensive Medications or for Which Conventional Incisional Glaucoma Surgery Would be More Likely to Fail Due to Scarring

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The objective of this early feasibility clinical study is to evaluate the safety and effectiveness of several different GORE Glaucoma Drainage Implant configurations in subjects with primary open-angle glaucoma that is uncontrolled by hypotensive medications or for which conventional incisional glaucoma surgery would be more likely to fail due to scarring.

Conditions

• Primary Open-angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Gore Glaucoma Device Implant (GORE GDI)	Unilateral implantation of one of three different configurations of the GORE GDI

Timeline

• Start date: 2022-09-14
• Primary completion: 2027-02-12
• Completion: 2031-08-01
• First posted: 2022-09-27
• Last updated: 2026-02-19

Locations

1 site across 1 country: Dominican Republic