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Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.
Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iStent inject | Active Comparator | Implantation of two iStent inject devices |
|
| Drug | Active Comparator | Travoprost drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStent inject | Device | Implantation of two iStent inject devices |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean diurnal IOP vs. screening | Month 24 | |
| Change in screening in time-wise IOPs | Various Month 12-60 | |
| Proportion of responders |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event reporting | Rate of ocular adverse events through 60 months
| 0-60 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lilit A Voskanyan, MD, PhD | S.V. Malayan Ophthalmological Center, Yerevan, Armenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.V. Malayan Ophthalmological Center | Yerevan | 0001 | Armenia |
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| Travoprost |
| Drug |
Travoprost drops |
|
A responder is defined as a subject with a certain target IOP value or a certain reduction of IOP as compared to screening. In the iStent inject group, a responder must not be on an ocular hypotensive medications or have had a postoperative procedure to reposition or remove stent(s) prior to the visit. Due to the lack of a complete consensus on the definition of a clinical responder, a set of target IOP values (e.g., downwards from 22 mm Hg in steps of 1 mm Hg) and reductions of IOP (e.g., downwards from the highest reduction in IOP in steps of 5%) will be evaluated. |
| Various 12-60 months |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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