Phase 4
Completed N=20
Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery
Source: ClinicalTrials.gov NCT00538590 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Apr 2012
Primary outcomePrimary: Postoperative Intraocular Pressure Change — -11.3; -11.6 mm Hg — p=0.95
Summary
To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Intraocular Pressure Change |
-13.3; -12.9 | 0.91 |
| PRIMARY Postoperative Intraocular Pressure Change |
-13.3; -12.9 | 0.91 |
| PRIMARY Postoperative Intraocular Pressure Change |
-13.3; -12.9 | 0.91 |
| PRIMARY Postoperative Intraocular Pressure Change |
-13.3; -12.9 | 0.91 |
| SECONDARY Complications |
15.6; 15.6 | — |
Eligibility Criteria
Inclusion Criteria
- Open angle glaucoma
- Maxima anti-glaucoma medication failed
- Age>18
- Able to complete the follow up
Exclusion Criteria
- Topical eye inflammation
- Angle closure glaucoma
- Deformity glaucoma
- One eye glaucoma
- Previous conjunctiva opened
- Allergy to collagen
Data sourced from ClinicalTrials.gov (NCT00538590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.