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A Multi Center Study Comparing the Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma
A prospective randomized trial to compare the safety and efficacy of the Ex-PRESS to trabeculectomy in patients with open angle glaucoma who failed medical or are allergic to medical treatment and for which filtering surgery is indicated. Surgical success was defined as 5 mmHg ≤ intraocular pressure ≤ 18 mmHg, with or without medications, without further glaucoma surgery. Postoperative intraocular pressure, number of medications, complications and success rates were followed for 2 years.
Details
| Lead sponsor | University of Virginia |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2006-10 |
| Completion | 2012-01 |
Conditions
- Glaucoma
Interventions
- Trabeculectomy
- Ex-PRESS mini shunt
Primary outcomes
- Postoperative Intraocular Pressure — assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported
Mean postoperative intraocular pressure - Medications — assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported
Countries
United States, Canada