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Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery (MCToCM)
The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) and Mitomycin-C (MMC) as adjuncts to filtration surgery in uncontrolled treated glaucoma cases, the efficacy being the primary objective and the safety being the secondary.
Details
| Lead sponsor | Aeon Astron Europe B.V. |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 99 |
| Start date | 2011-09 |
| Completion | 2015-12 |
Conditions
- Glaucoma
Interventions
- Use of ologen Collagen Matrix in trabeculectomy (ologen)
- Use of Mitomycin-C (MMC) in trabeculectomy
Primary outcomes
- Intraocular pressure(IOP) reduction — At postoperative up to 24 months.
"Complete success" is consider for IOP less than 21mmHg(inclusive) with no glaucoma medications and with more than 20% reduction(inclusive) from baseline IOP. Definition of success rate is calculated in percentage by the number of complete success patients over the total sample size. "Qualified success" that meets the postoperative IOP requirements with postoperative glaucoma medicaitons and "Failure" of meeting the IOP requirements are the other efficacy parameters. In the specified time frame, patients will also visit for record at day 1, 7, 14, 30, 90, 180 days, 12, 18, and 24 months.
Countries
United States