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A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
To evaluate the safety and effectiveness of VisiPlate Aqueous Shunt to lower intraocular pressure (IOP) in subjects with open-angle glaucoma for whom medical and surgical treatments have failed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VisiPlate Glaucoma Implant | Device | Implant (micro-shunt) for glaucoma patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure | The eye is filled with a special fluid. The intraocular pressure is the amount of fluid that builds up in the eye. The primary outcome is the number of people whose eye pressure went down by at least 20%. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in mean diurnal IOP | How much the average eye pressure during the day went up or down, shown as a percent. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine Lee | Contact | 12816100251 | kati@avisitech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Advanced Eye Research | Recruiting | Glendale | Arizona | 85306 | United States | |
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| Sacramento Eye Consultants |
| Recruiting |
| Sacramento |
| California |
| 95815 |
| United States |
| ICON Eye Care | Recruiting | Grand Junction | Colorado | 81501 | United States |
| Mile High Eye Institute | Withdrawn | Sheridan | Colorado | 80226 | United States |
| Cleveland Clinic- Cole Eye Institute | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
| Scheie Eye Institute | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Wills Eye Hospital | Not yet recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Glaucoma Associates of Texas | Recruiting | Dallas | Texas | 75231 | United States |
| University of Texas Southwestern | Not yet recruiting | Dallas | Texas | 75390 | United States |
| The Eye Centers of Racine & Kenosha | Recruiting | Kenosha | Wisconsin | 53142 | United States |
| Lynette Venter | Not yet recruiting | Bloemfontein | 9301 | South Africa |
| Pretoria Eye Institute | Not yet recruiting | Pretoria | 0007 | South Africa |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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