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| ID | Type | Description | Link |
|---|---|---|---|
| OculusGen-2006-02-20 |
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The purpose of this study is to compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OculusGen Biodegradable Collagen Matrix Implant | Experimental | Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant |
|
| MMC | Active Comparator | Trabeculectomy with MMC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OculusGen Biodegradable Collagen Matrix Implant | Device | Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| the effectiveness via the reduction of IOP | 180 day |
| Measure | Description | Time Frame |
|---|---|---|
| the safety via the incidence of complications and adverse events. | 180 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arslan Tsai, Pharma | Contact | +886 2 27088558 | 116 | arslan.tsai@aeonastron.net |
| Name | Affiliation | Role |
|---|---|---|
| Rajul S Parikh, MD | V. S. T. Glaucoma Services, L. V. Prasad Eye Institute, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L. V. Prasad Eye Institute | Recruiting | Hyderabad | Andhra Pradesh | 500 034 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17122118 | Result | Chen HS, Ritch R, Krupin T, Hsu WC. Control of filtering bleb structure through tissue bioengineering: An animal model. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5310-4. doi: 10.1167/iovs.06-0378. | |
| 10937547 | Result | Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Trabeculectomy with MMC | Drug | Trabeculectomy with MMC |
|
| 36912740 | Derived | Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3. |