Ologen(Oculusgen)-Glaucoma and Pterygium Historical Control Study in China Shanghai Sixth People's Hospital

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

Detailed Description
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ologen (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 Ologen(OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery

Conditions
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Glaucomas, Pterygium

Intervention / Treatment
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* Device: ologen™ Collagen matrix implantation in glaucoma filtering surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or over Patient able to cooperate with study procedures and able to perform tests reliably Patient willing to sign informed consent Patient able and willing to complete postoperative follow-up requirements Glaucoma：one/both eyes are affected by glaucoma Pterygium： patient with pterygium Exclusion Criteria: Known allergic reactions to collagen

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ologen™ collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy. After operation with ologen™ Collagen Matrix, anti-inflammatory eye-drops will be prescribed | Device: ologen™ Collagen matrix implantation in glaucoma filtering surgery<br>* ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.<br>* Other names: Oculusgen™ (ologen™);|

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 and the incidence of pterygium recurrence |  | 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, Pterygium, collagen matrix, OculusGen, trabeculectomy, Anti scarring, pterygium recurrence, tissue engineering, ologen, Aeon Astron