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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gore GDI High Device Arm | Experimental | Implantation of the GORE GDI High Device Configuration |
|
| Gore GDI Low Device Arm | Experimental | Implantation of the GORE GDI Low Device Configuration |
|
| GORE GDI Modified Device Arm | Experimental | Non-Randomized implantation of the GORE GDI Modified Device Configuration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gore Glaucoma Device Implant (GORE GDI) | Device | Unilateral implantation of one of three different configurations of the GORE GDI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan F Batlle Pichardo, M.D. | Laser Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Center | Santo Domingo | Dominican Republic |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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