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Difficulty obtaining IDE by the FDA. Currently not worthwhile to pursue further.
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Investigators hypothesize that the synergistic action of iStent in increasing aqueous outflow through the trabecular meshwork and use of prostaglandin analog such as travoprost or latanoprost to increase uveoscleral outflow will achieve good Intra-ocular Pressure (IOP) control with minimal complications in Primary Open Angle Glaucoma (POAG) patients with suboptimal IOP on 2 or more medications compared to mitomycin C (MMC) augmented trabeculectomy.
This will be a prospective randomized controlled study.
20 phakic or pseudophakic open angle glaucoma patients with an IOP in the range of 18-30 mmHg on 2 or more topical glaucoma medications will be randomly selected to undergo either (1) mitomycin-augmented trabeculectomy or (2) placement of 2 iStent devices and initiation of a daily prostaglandin analog. This study is looking at the combined effects of the 2 iStents and a prostaglandin analog as a method to achieve low IOP. At 3 months (+/- 2 weeks) postoperatively, the iStent patients will be left only on the prostaglandin analog with a washout performed for any other hypotensive medication used. Patients who had a trabeculectomy will be have a terminal washout of all IOP-lowering medications at 3 months (+/- 2 weeks) post-surgery. The IOP will then be measured for both groups at 4 months (+/- 3 weeks) postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 iStent with travoprost or latanoprost | Experimental | 2 iStents will be injected into the trabecular meshwork and patients will be administered topical latanoprost or travoprost following surgery |
|
| trabeculectomy | Active Comparator | Standard trabeculectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStent and travoprost or latanoprost | Device | 2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| IOP <= 18 mmHg | IOP | Post surgery month 4 |
| IOP <= 15 mmHg | IOP | Post surgery month 4 |
| IOP >= 20% reduction from untreated baseline | IOP | Post surgery month 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Trabeculectomy | Procedure | Standard trabeculectomy |
|