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To establish the clinical performance of the SOLX Gold Shunt for its ability to reduce intraocular pressure (IOP) in eyes with refractory glaucoma where medical and conventional surgical treatments have failed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOLX Gold Shunt | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOLX Gold Shunt | Device | Single use implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Average change in IOP | 1 & 2 years | |
| Percentage change in IOP from baseline | 1 & 2 years | |
| Average change in number of glaucoma medications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nilay Shah, MD | The Emmes Company, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Vold Vision, PLLC |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| 1 & 2 years |
| Visual acuity changes | 1 & 2 years |
| Springdale |
| Arkansas |
| 72762 |
| United States |
| University of California, Irvine | Irvine | California | 92697 | United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| Illinois Eye Institute | Chicago | Illinois | 60616 | United States |
| Glaucoma Associates of New York | New York | New York | 10003 | United States |
| Ophthalmic Partners of Pennsylvania | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| University Eye Surgeons | Maryville | Tennessee | 37803 | United States |
| Glaucoma Associates of Texas | Dallas | Texas | 75231 | United States |
| University of Virginia | Charlottsville | Virginia | 22908 | United States |
| Memmen, Ltd | Green Bay | Wisconsin | 54304 | United States |
| University of Campinas | Campinas | Brazil |
| Clarity Eye Institute | Vaughan | Ontario | L4K 0C5 | Canada |
| Institut de l'oeil des Laurentides | Boisbriand | Quebec | J7H 1S6 | Canada |
| Bellevue Ophthalmology Clinic | Montreal | Quebec | H1V 1G5 | Canada |
| Medical Research Infrastructure Department and Health Services Fund by the Sheba Medical Center (R.A.) | Tel Litwinsky | 52621 | Israel |
| Centro Medico Docente La Trinidad | Caracas | 1080-A | Venezuela |