Status:
UNKNOWN
Ologen (OculusGen)-Glaucoma MMC Control Trial in India
Lead Sponsor:
Pro Top & Mediking Company Limited
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00449098
Start Date
January 1 2007
End Date
October 1 2011
Last Update
October 7 2011
Active Locations (1)
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1
L. V. Prasad Eye Institute
Hyderabad, Andhra Pradesh, India, 500 034