drugset / Trial / NCT03506542

Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C

NCT03506542

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

EvaluationDrugModalityDoseRoute
Comparator Mitomycin C Other / unclassified 0.3 mg/ml Other

Indications