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To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.
A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys Microfistula Implant in refractory glaucoma patients who have previously failed a glaucoma procedure and who are not well-controlled on IOP lowering medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AqueSys Microfistula Implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AqueSys Microfistula Implant | Device | Placement of the AqueSys Microfistula Implant in the study eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in IOP from baseline | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard A Lewis, M.D. | Grutzmacher and Lewis Surgical Eye Specialists | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vold Vision, PLLC | Fayetteville | Arkansas | 72704 | United States | ||
| USC Eye Institute, University of Southern California |
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| Los Angeles |
| California |
| 90033 |
| United States |
| Scripps Clinic | San Diego | California | 92037 | United States |
| Ophthalmic Consultants of Connecticut | Fairfield | Connecticut | 06824 | United States |
| Bascom Palmer Eye Institute, University of Miami | Miami | Florida | 33136 | United States |
| Stiles Eyecare Excellence and Glaucoma Institute | Overland Park | Kansas | 66213 | United States |
| Minnesota Eye Consultants, PA | Bloomington | Minnesota | 55431 | United States |
| Eye Care Associates & Glaucoma Consultants of Long Island | Bethpage | New York | 11714 | United States |
| New York Eye and Ear Infirmary | New York | New York | 10003 | United States |
| Vanderbilt Eye Institute | Nashville | Tennessee | 37232 | United States |
| Texan Eye | Austin | Texas | 78731 | United States |
| Glaucoma Associates of Texas | Dallas | Texas | 75231 | United States |
| UVA Eye Clinic, University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Spokane Eye Clinic | Spokane | Washington | 99204 | United States |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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