Open-angle Glaucoma Clinical Trial
Official title:
A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy
The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.
ologen® Collagen Matrix (CM) is an artificial extracellular matrix (ECM) specifically
configured to support repair in connective and epithelial ocular tissue. The device is
constructed so as to minimize random growth of fibroblasts and instead to allow them to grow
through the pores in the matrix. ologen® CM is a biodegradable scaffold matrix, inducing a
regenerative non-scarring wound healing process without using anti-fibrotic agents. For
application in glaucoma filtration surgery, ologen® CM is designed to prevent scar formation
(subconjunctival and scleral flap scarring is the major risk factor for failure of
trabeculectomy). After implanting the ologen® CM on top of the scleral flap in the
subconjunctival space, a functional bleb can be created.
The aim of the present study is to determine the effectiveness of the ologen® CM and reduce
wound scarring, thereby increasing success of trabeculectomy without side effects of MMC. A
means of producing better success rate and reduced complications is the purpose of ologen®
Collagen Matrix for the aid of glaucoma surgery.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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