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Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.
Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iStent and iStent supra | Other | Implantation of two iStent devices and one iStent supra device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStent and iStent supra | Device | Implantation of two iStent devices and one iStent supra device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP | Primary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP, had no glaucoma surgical procedures (incisional or laser surgery prior to the 12 month visit), and no postoperative procedure to reposition or remove the stent prior to the 12 month visit, or additional ocular hypotensive medications within 4 weeks of the Month 12 visit | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean diurnal IOP < 18mm Hg | Secondary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP < 18 mmHg, had no glaucoma surgical procedures (incisional or laser surgery) prior to the 12 month visit, and no postoperative procedure to reposition or remove the stent prior to the 12 month visit or additional ocular hypotensive medications within 4 weeks of the Month 12 visit | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety/adverse event monitoring | Rate of ocular adverse events through 61 months
| 0-61 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29476443 | Derived | Myers JS, Masood I, Hornbeak DM, Belda JI, Auffarth G, Junemann A, Giamporcaro JE, Martinez-de-la-Casa JM, Ahmed IIK, Voskanyan L, Katz LJ. Prospective Evaluation of Two iStent(R) Trabecular Stents, One iStent Supra(R) Suprachoroidal Stent, and Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes. Adv Ther. 2018 Mar;35(3):395-407. doi: 10.1007/s12325-018-0666-4. Epub 2018 Feb 23. |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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