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.