Ologen (OculusGen)-Glaucoma MMC Control Trial in India

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Pro Top & Mediking Company Limited
Updated on 7 November 2020
trabeculectomy
filtration surgery

Summary

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.

Description

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.

Details
Condition Glaucoma
Treatment OculusGen Biodegradable Collagen Matrix Implant, Trabeculectomy with MMC
Clinical Study IdentifierNCT00449098
SponsorPro Top & Mediking Company Limited
Last Modified on7 November 2020

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