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Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iStent inject | Experimental | Implantation of two GTS400 stents using G2-M-IS iStent inject |
|
| Cataract surgery | Active Comparator | Cataract surgery alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStent inject | Device | Implantation of two GTS400 stents using G2-M-IS iStent inject |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ≥ 20% Reduction in Intraocular Pressure (IOP) | Baseline and Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Diurnal IOP Reduction from Baseline | Baseline and Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety follow-up post-PMA to be through 36 months | 36 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerry Stephens, O.D. | Glaukos Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Centers of Racine and Kenosha | Racine | Wisconsin | 53405 | United States |
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| Cataract surgery |
| Procedure |
Cataract surgery alone |
|
| 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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