drugset / Trial / NCT03506542
Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C
RandomizedParallel-groupOpen-labelTreatment
Summary
1. Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®; OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented phacotrabeculectomy. 2. Study Design: The study is designed as a prospective randomized trial. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study. 3. Follow-Up: This investigation is including 7 post-operative visits and follow-up within 12 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 30, 90, 180, 270 and 360.
Timeline
- Start
- 2014-06-02
- Primary completion
- 2016-03-01
- Completion
- 2017-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mitomycin C | Other / unclassified | 0.3 mg/ml | Other |