"ologen ® CM" is a biodegradable collagen matrix. To prevent episcleral fibrosis and subconjunctival scarring thay may result in the surgical failure in trabeculectomy, its sporous matrix modulates the migrations and proliferations of fibroblasts to create a vascular and long-lasting bleb without the adverse effects, such as avascular thin bleb wall, bleb leak, hypotony, and inflammations, potentially caused by the regeneration suppression effects upon the use of cytotoxic agents as anti-fibrotic agents, such as MMC (Mitomycin-C)in the study.
Results of ologen CM studies have been published at conferences and published in peer-reviewed journals; ologen CM is approved in Europe as an aid for tissue repair, and by the FDA in the US as an adjunct in wound management(K080868). In general, over 6,000 ologen CM have been implanted worldwide during the past two years with good results and excellent safety profile.
The clinical trial is a phase-IV post-marketing FDA approved device study designed as open-label, randomised, parallel, and comparative. 128 patients at 8 sites are anticipated to be recruited according to the enrollment criteria, while randomisation will be assigned by a sealed envelope system after the patient has signed consent. Trabeculectomy is performed thereafter with either MMC or ologen CM applications as described in the protocol with postoperative parameters to be measured and analysed with non-parametric tests(Chi-square, Fisher's exact, Wilcoxon, and Mann-Whitney tests) as well as Kaplan-Meier survival models.
