Oculusgen (Ologen) Glaucoma MMC Control in Estonia
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Purpose
To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC) in glaucoma surgery.
The ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. The MMC application is as the standard.
| Condition | Intervention | Phase |
|---|---|---|
|
Open Angle Glaucoma Angle Closure Glaucoma Uveitis Glaucoma Young Age Glaucoma Neovascular Glaucoma High Risk Patient |
Device: ologen (oculusgen) collagen matrix Drug: MMC in Trabeculectomy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery |
- IOP <21mmHg without anti glaucoma medication [ Time Frame: 180 days ] [ Designated as safety issue: No ]
- IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication [ Time Frame: 180-day ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ologen in Trabeculectomy
Ologen in Trabeculectomy
|
Device: ologen (oculusgen) collagen matrix
Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed.
Other Names:
|
|
Active Comparator: MMC in Trabeculectomy
MMC in Trabeculectomy
|
Drug: MMC in Trabeculectomy
MMC in Trabeculectomy
|
Detailed Description:
Ologen collagen matrix is implanted on the top of sclera flap after the loose stich sclera flap is done for the filtering surgery. The concept of ologen collagen matrix is to creat the subconjunctiva bleb and modulate the wound healing for the surgery. By implanting ologen collagen matrix in the place, subconjuctival and trabdoor scars might be prevented. This is because the ologen collagen matrix is a 3-D scaffold porous structure that can guide fibroblast to grow randomly, instead of linear alignment. This can reduce the scar formation.
Doctors apply MMC for the glaucoma surgery is also trying to inhibite the scar formation. But MMC has been long time used and glaucoma specialists have not found anything to replace it.
Ologen collagen matrix concept is not INHIBITION, it is guiding and creating a physiological tissue. The successful of ologen collagen matrix may be on par with MMC but the safety and side effects will be much less.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Max anti glaucoma medication failed,
Exclusion Criteria:
- Age less than 18, woman in pregnant, hemodialysis patient
Contacts and Locations| Contact: Arslan Tsai, Pharma/ MSc EFM | +886 2 27088558 ext 116 | arslan.tsai@aeonastron.net |
| Estonia | |
| Tartu University Clinics | Recruiting |
| Tartu, Estonia | |
| Contact: Kuldar Kaljurand, MD +372 737 6189 kristel.mikkor@ut.ee | |
| Principal Investigator: Kuldar Kaljurand, MD | |
| Principal Investigator: | Kuldar Kaljurand, MD | University of Tartu |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pro Top & Mediking Company Limited |
| ClinicalTrials.gov Identifier: | NCT00524758 History of Changes |
| Other Study ID Numbers: | oculusgen 2006-02-20 |
| Study First Received: | September 4, 2007 |
| Last Updated: | October 24, 2011 |
| Health Authority: | Estonia: Ministry of Health |
Keywords provided by Pro Top & Mediking Company Limited:
|
ologen oculusgen collagen matrix trabeculectomy |
filtering surgery mitomycin-C MMC Aeon Astron |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Angle-Closure Glaucoma, Neovascular Glaucoma, Open-Angle Uveitis Chorioretinitis Ocular Hypertension Eye Diseases Uveal Diseases Retinitis Retinal Diseases Choroiditis |
Choroid Diseases Uveitis, Posterior Panuveitis Mitomycin Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Alkylating Agents Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013