Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India

Study Overview
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Brief Summary
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. Study Objective: The objective of this study is to determine the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in phacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the reduction of Intraocular Pressure, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events. . Study Design: The study is designed as a historical controlled study. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study. The allocation of subjects is non-randomized, and there is a single group for assignment. . Follow-Up: This investigation is including 7 post-operative visits and follow-up within 6 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 14, 30, 60, 90 and 180. The visit window of ± 7 days is allowed for the 30, 60, 90 and 180 day visits. The further follow-up of subject after trial is continually tracked by the investigator.

Detailed Description
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ologen collagen matrix is applied for the phacotrabec surgery.

Official Title
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Study of the Safety and Effectiveness of the OculusGenTM Collagen Matrix Implant as an Aid in Phacotrabeculectomy Surgery

Conditions
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Glaucoma, Cataract

Intervention / Treatment
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* Device: OculusGen Biodegradable Collagen Matrix Implant


Participation Criteria
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Eligibility Criteria
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Subject inclusion criteria: 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. Subject exclusion criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OculusGen Collagen Matrix<br>OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy. | Device: OculusGen Biodegradable Collagen Matrix Implant<br>* OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative and Postoperative Intraocular Pressure | The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days. | baseline and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Any Complications or Adverse Events. | Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis. | 180 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Collagen matrix, OculusGen, Phacotrabeculectomy, anti scarring, tissue engineering, ologen, Aeon Astron