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Sponsored by: |
Pro Top & Mediking Company Limited |
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Information provided by: | Pro Top & Mediking Company Limited |
ClinicalTrials.gov Identifier: | NCT00687791 |
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 prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.
Condition | Intervention | Phase |
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Cataract Glaucoma |
Device: ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study |
Estimated Enrollment: | 20 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
20 enrolled patients will be chosen according to the enrollment acceptance criteria. The evidence for the determination of enrolled patients shall be recorded, reviewed and approved. 2> Phacotrabeculectomy is performed.3> After completing phacotrabeculectomy, implant/place ologen™ Collagen Matrix on top of the scleral flap under the conjunctiva. For every inspection and observation, the detailed description and/or inspection data shall be recorded. If any unwanted adverse event is observed during inspection and observation, it shall be recorded and be reported to the investigation conductor.
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Device: ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery
Study of the safety and effectiveness of the ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery
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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 traditional filtering surgery (trabeculectomy)
Within 60 days from the time of implantation, ologen™ Collagen Matrix is totally degraded. Postoperatively, mild inflammation may be seen and anti- inflammatory agents are prescribed
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aung Tin, PhD MD | +65-62277255 | aung.tin@snec.com.sg |
Singapore | |
Singapore Eye Research Institute | Recruiting |
Singapore, Singapore, 168751 |
Study Chair: | Aung Tin, PhD MD | Singapore Eye Research Institute |
Responsible Party: | Singapore Eye Research Institute ( Assoc. Prof. Aung Tin ) |
Study ID Numbers: | Mediking 0706 |
Study First Received: | May 28, 2008 |
Last Updated: | June 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00687791 |
Health Authority: | Singapore: Ministry of Health |
patients with cataract and glaucoma ologen oculusgen collagen matrix Phacotrabeculectomy |
Aeon Astron trabeculectomy tissue engineering mitomycin-C |
Glaucoma Eye Diseases Cataract Mitomycin |
Lens Diseases Mitomycins Hypertension Ocular Hypertension |