Status:
COMPLETED
Ologen (OculusGen)-Glaucoma Case Control Trial in India
Lead Sponsor:
Pro Top & Mediking Company Limited
Conditions:
Glaucoma
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the safety and effectiveness of trabeculectomy with ologen (OculusGen) Biodegradable Collagen Matrix Implant and trabeculectomy without antifibrotic agents.
Detailed Description
1. Study Objective: To determine the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant in filtration surgery. The primary endpoint is to prove the effectiveness ...
Eligibility Criteria
Inclusion
- Age 30 years or over.
- No previous intraocular operative surgery
- 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 porcine collagen.
- Subject is on warfarin and discontinuation is not recommended.
- Patient who has been diagnosed for one of following glaucoma: normal tension glaucoma, uveitic glaucoma, aphakia or pseudophakia glaucoma, neovascular glaucoma and other classified secondary glaucoma.
- Participation in an investigational study during the 30 days proceeding 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 :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00448929
Start Date
January 1 2007
End Date
October 1 2011
Last Update
June 27 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
L. V. Prasad Eye Institute
Hyderabad, Andhra Pradesh, India, 500 034