Status:
UNKNOWN
Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study
Lead Sponsor:
Pro Top & Mediking Company Limited
Conditions:
Cataract
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to determine the safety and effectiveness of the OculusGen™ (ologen) Biodegradable Collagen Matrix Implant in hacotrabeculectomy surgery. The primary endpoint is to prov...
Detailed Description
Ologen™ Collagen Matrix is indicated for creating a mature bleb structure to facilitate aqueous outflow for the reduction of elevated intraocular pressure in patients with glaucoma, following traditio...
Eligibility Criteria
Inclusion
- Age 18 years or over.
- At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
- Visually significant cataract with visual acuity of less than or equal to 6/12.
- Subject able and willing to cooperate with investigation plan.
- Subject willing to sign informed consent form.
Exclusion
- Known allergic reaction to collagen.
- Subject is on Warfarin and discontinuation is not recommended.
- Subject with normal tension glaucoma or aphakic glaucoma.
- Subject with corneal disease.
- Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.
- Ocular infection within 14 days prior to phacotrabeculectomy.
- Pregnant or breast-feeding women.
- Monocular subject.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00687791
Start Date
December 1 2007
End Date
December 1 2008
Last Update
June 18 2008
Active Locations (1)
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1
Singapore Eye Research Institute
Singapore, Singapore, 168751