Cataract Clinical Trial
Official title:
Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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