OculusGen-Glaucoma Historical Control Study in Taiwan

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery.

Detailed Description
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OculusGen® Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

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

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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Subject inclusion criteria: Age 18 years or over. At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy. 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. Subject exclusion criteria: Have allergic reactions to collagen Subject is taking anticoagulation and/or the physician does not suggested to stop taking the medication Normal tension glaucoma patient Subject has one eye received OculusGen™ implantation Subject who been diagnosed infection with the operation eye Subject with anterior chamber abnormality Subject with steroid glaucoma

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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OculusGen Biodegradable Collagen Matrix Implant|nan|

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. |  | 180day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OculusGen, Glaucoma, collagen matrix, trabeculectomy, tissue engineering