Ologen (OculusGen)-Glaucoma Case Control Trial in India

Study Overview
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Brief Summary
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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
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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 via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events. Study Design: The study is designed as an open-label, randomized, parallel, comparative study. Patients who meet the inclusion/exclusion criteria and sign informed consent will be included. After enrollment, patients will be randomized into two groups: trabeculectomy with OculusGen implant or trabeculectomy without antifibrotics. Follow-Up: There will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. A window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. Further follow-up of subjects after the trial will be the responsibility of the investigator.

Official Title
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Comparative Study of the Safety and Effectiveness Between Trabeculectomy and Trabeculectomy With Ologen (OculusGen) Collagen Matrix Implant

Conditions
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Glaucoma

Intervention / Treatment
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* Device: OculusGen Biodegradable Collagen Matrix Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 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: Trabeculectomy with Oculusgen<br> | Device: OculusGen Biodegradable Collagen Matrix Implant<br>* Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant<br>|
| No Intervention: Trabeculectomy without Oculusgen or antifibrotic agents<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effectiveness via the reduction of IOP |  | 180 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the safety via the incidence of complications and adverse events. |  | 180 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Collagen matrix, ologen, OculusGen, Trabeculectomy