Glaucoma Clinical Trial
Official title:
Comparative Study of the Safety and Effectiveness Between Ologen (OculusGen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery
The purpose of this study is to compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.
1. Study Objective: To compare the safety and effectiveness of the ologen (OculusGen)
Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery. The
primary endpoint is to prove the effectiveness via the reduction of IOP, and the
secondary endpoint is to prove the safety via the incidence of complications and
adverse events.
2. Study Design: The study is designed as an open-label, randomized, parallel, comparative
study. Patients who meet the inclusion/exclusion criteria and sign informed consent
will be included. After enrollment, patients will be randomized into two groups:
trabeculectomy with ologen (OculusGen) implant or trabeculectomy with mitomycin-C.
3. Follow-Up: There will be 7 post-operative and follow-up visits within 6 months of
surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. A window of ± 7 days is
allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. Further
follow-up of subjects after the trial will be the responsibility of the investigator.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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