Status:
COMPLETED
Ologen (OculusGen)-Glaucoma MMC Control in Pakistan
Lead Sponsor:
Pro Top & Mediking Company Limited
Conditions:
Glaucoma
Trabeculectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed 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 th...
Eligibility Criteria
Inclusion
- 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
- Known allergic reaction to mitomycin-C or Bovine 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00472810
Start Date
March 1 2007
Last Update
October 7 2011
Active Locations (1)
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1
RMC & Allied Hospital
Rawalpindi, Punjab Province, Pakistan