Oculusgen (Ologen) Glaucoma MMC Control in Estonia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery

Conditions
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Open Angle Glaucoma, Angle Closure Glaucoma, Uveitis Glaucoma, Young Age Glaucoma, Neovascular Glaucoma, High Risk Patient

Intervention / Treatment
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* Device: ologen (oculusgen) collagen matrix
* Drug: MMC in Trabeculectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Max anti glaucoma medication failed, Exclusion Criteria: Age less than 18, woman in pregnant, hemodialysis patient

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ologen in Trabeculectomy<br>Ologen in Trabeculectomy | Device: ologen (oculusgen) collagen matrix<br>* Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed.<br>* Other names: oculusgen collagen matrix;|
| Active Comparator: MMC in Trabeculectomy<br>MMC in Trabeculectomy | Drug: MMC in Trabeculectomy<br>* MMC in Trabeculectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP <21mmHg without anti glaucoma medication |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication |  | 180-day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ologen, oculusgen, collagen matrix, trabeculectomy, filtering surgery, mitomycin-C, MMC, Aeon Astron