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The objective of this study is to determine the safety and effectiveness of the OculusGen™ (ologen) Biodegradable Collagen Matrix Implant in hacotrabeculectomy 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.
Ologen™ Collagen Matrix is indicated for creating a mature bleb structure to facilitate aqueous outflow for the reduction of elevated intraocular pressure in patients with glaucoma, following traditional filtering surgery (trabeculectomy)
Within 60 days from the time of implantation, ologen™ Collagen Matrix is totally degraded. Postoperatively, mild inflammation may be seen and anti- inflammatory agents are prescribed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 20 enrolled patients will be chosen according to the enrollment acceptance criteria. The evidence for the determination of enrolled patients shall be recorded, reviewed and approved. 2> Phacotrabeculectomy is performed.3> After completing phacotrabeculectomy, implant/place ologen™ Collagen Matrix on top of the scleral flap under the conjunctiva. For every inspection and observation, the detailed description and/or inspection data shall be recorded. If any unwanted adverse event is observed during inspection and observation, it shall be recorded and be reported to the investigation conductor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery | Device | Study of the safety and effectiveness of the ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is to prove the effectiveness via the reduction of IOP. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| the secondary endpoint is to prove the safety via the reduction of complications. | 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aung Tin, PhD MD | Contact | +65-62277255 | aung.tin@snec.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Aung Tin, PhD MD | Singapore Eye Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore Eye Research Institute | Recruiting | Singapore | 168751 | Singapore |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D009798 | Ocular Hypertension |
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