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To evaluate the safety and effectiveness of Trabecular Micro-Bypass stents (two stents per study eye) vs. laser trabeculoplasty, in subjects with open angle glaucoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical | Experimental | Implantation of two Trabecular Meshwork stents into the study eye |
|
| Laser | Active Comparator | Laser Trabeculoplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stents | Device | Two Trabecular meshwork Micro-Bypass stents into the study eye |
| |
| Measure | Description | Time Frame |
|---|---|---|
| IOP reduction | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| % IOP reduction | up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerry Stephens, OD | Glaukos Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | Arizona | 85306 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35943114 | Derived | Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3. |
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| Laser |
| Procedure |
Laser Trabeculoplasty |
|
| Laser Trabeculoplasty | Device |
|
| Fayetteville |
| Arkansas |
| 72704 |
| United States |
| Hemet | California | 92545 | United States |
| Cape Coral | Florida | 33904 | United States |
| Elizabeth City | North Carolina | 27909 | United States |
| Memphis | Tennessee | 38120 | United States |
| Fort Worth | Texas | 76102 | United States |
| San Antonio | Texas | 78229 | United States |
| Racine | Wisconsin | 53405 | United States |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D055096 | Optical Devices |
| D055618 | Radiation Equipment and Supplies |
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