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
Overview
- Phase
- N/A
- Intervention
- Gore Glaucoma Device Implant (GORE GDI)
- Conditions
- Primary Open-angle Glaucoma
- Sponsor
- W.L.Gore & Associates
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Primary Effectiveness Endpoint
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females, age 18 to 85 years, inclusive at screening visit
- •A diagnosis of primary open-angle glaucoma (Shaffer angle ≥ 3 as seen on gonioscopy) at screening visit
- •Medicated intraocular pressure at screening visit and the mean medicated diurnal IOP at baseline visit ≥ 18 mmHg and ≤ 40 mmHg by Goldmann Applanation Tonometry
Exclusion Criteria
- •Expected inability to implant the study device in the superotemporal quadrant (e.g., a lack of freely mobile conjunctiva to cover the entire implanted device in the superotemporal quadrant)
- •Diagnosis of any active ocular disease or disorder (other than glaucoma) that requires treatment, where the disease or treatment could be reasonably expected to affect the vision or IOP during the duration of the study
- •Prior corneal transplant surgery (full or partial thickness transplants) or clinically significant corneal dystrophy, e.g., Fuchs' dystrophy (\> 12 confluent guttae) in the study eye
- •Concurrent cataract surgery or anticipated need for cataract surgery (i.e., clinically significant cataract) in the study eye during the 12 months following implantation
- •BCDVA worse than 20/200 in the fellow (non-study) eye at the screening visit and BCDVA of the fellow eye cannot be worse than that of the study eye.
Arms & Interventions
Gore GDI High Device Arm
Implantation of the GORE GDI High Device Configuration
Intervention: Gore Glaucoma Device Implant (GORE GDI)
Gore GDI Low Device Arm
Implantation of the GORE GDI Low Device Configuration
Intervention: Gore Glaucoma Device Implant (GORE GDI)
GORE GDI Modified Device Arm
Non-Randomized implantation of the GORE GDI Modified Device Configuration
Intervention: Gore Glaucoma Device Implant (GORE GDI)
Outcomes
Primary Outcomes
Primary Effectiveness Endpoint
Time Frame: 6 months
The proportion of treated eyes with ≥ 20% decrease in mean diurnal IOP at 6 months while maintaining the same or fewer number of hypotensive medications as at baseline.