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The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iStent | Experimental | Implantation of one iStent in conjunction with cataract surgery |
|
| Cataract surgery | Active Comparator | Cataract surgery alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStent | Device | Implantation of one iStent in conjunction with cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of sight-threatening adverse events | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Other adverse events | For other adverse events such as increase in intra-ocular pressure (IOP) of ≥ 10 mmHg at any time postoperative, loss of best spectacle corrected visual acuity of ≥ 2 lines (≥ 10 letters) postoperative as compared to baseline or best recorded visual acuity measured at any visit postoperative, the rate of each event at each visit will be calculated for the two treatment groups separately. |
| Measure | Description | Time Frame |
|---|---|---|
| Diurnal IOP reduction ≥ 20% | Baseline and 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irvine | California | 92604 | United States | |||
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| Cataract surgery | Procedure | Cataract surgery alone |
|
| 36 months |
| Montebello |
| California |
| 90640 |
| United States |
| Aurora | Colorado | 80045 | United States |
| Atlanta | Georgia | 30342 | United States |
| Edgewood | Kentucky | 41017 | United States |
| Louisville | Kentucky | 40217 | United States |
| Jackson | Michigan | 49202 | United States |
| Saint Joseph | Michigan | 49085 | United States |
| Kansas City | Missouri | 64151 | United States |
| St Louis | Missouri | 63131 | United States |
| Winston-Salem | North Carolina | 27101 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Mentor | Ohio | 44060 | United States |
| Kingston | Pennsylvania | 18704 | United States |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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