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The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One iStent Supra Stent and medication | Experimental | The study assesses the efficacy and safety of one iStent Supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStent Supra Stent | Device | Implantation of one iStent Supra Stent through a small temporal clear corneal incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean diurnal Intraocular Pressure < 18 mmHg at month 12 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Rate of ocular adverse events through 61 months
| 0-61 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lilit Voskanyan, MD | SV Malayan Ophthalmological Center, Yerevan, Armenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.V. Malayan Ophthalmology Centre | Yerevan | 375108 | Armenia |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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