Overview

Ologen (OculusGen)-Glaucoma MMC Control Trial in India

Status:
Unknown status
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pro Top & Mediking Company Limited
Criteria
Inclusion Criteria:

- Age 18 years or over.

- Uncontrolled glaucoma, with failed medical and laser treatment, requiring
trabeculectomy.

- Subject able and willing to cooperate with investigation plan.

- Subject able and willing to complete postoperative follow-up requirements.

- Subject willing to sign informed consent form.

Exclusion Criteria:

- Known allergic reaction to mitomycin-C or porcine collagen.

- Subject is on warfarin and discontinuation is not recommended.

- Normal tension glaucoma.

- Participation in an investigational study during the 30 days preceding trabeculectomy.

- Ocular infection within 14 days prior to trabeculectomy.

- Pregnant or breast-feeding women.