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The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Arm: One iStent, medication | Experimental | Device: One iStent, medication |
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| Second Arm: Two iStents, medication | Experimental | Device: Two iStent devices, medication |
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| Third Arm: Three iStents, medication | Experimental | Device: Three iStent devices, medication |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStent | Device | Implantation of One iStent through a small temporal clear corneal incision. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean diurnal IOP <18 mmHg at month 12 | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.V. Malayan's Ophthalmology Centre | Yerevan | 375108 | Armenia |
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iStent 1, 2, or 3 stents
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| iStent | Device | Implantation of Two iStents through a small temporal clear corneal incision |
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| iStent | Device | Implantation of Three iStents through a small temperal clear corneal incision |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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