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GORE Glaucoma Drainage Implant Clinical Study Dominican Republic
Sponsor: W.L.Gore & Associates
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2022-09-14
Completion Date
2031-08
Last Updated
2026-02-19
Healthy Volunteers
Yes
Conditions
Interventions
Gore Glaucoma Device Implant (GORE GDI)
Unilateral implantation of one of three different configurations of the GORE GDI
Locations (1)
Laser Center
Santo Domingo, Dominican Republic