Congenital Glaucoma Clinical Trial
Official title:
Comparative Evaluation of Combined Trabeculotomy-trabeculectomy Versus Combined Trabeculotomy-trabeculectomy With Subconjunctival Implantation of Collagen Matrix Implant for Primary Congenital Glaucoma.
The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) as adjunct to combined trabeculotomy-trabecuectomy in congenital glaucoma cases, the efficacy being the primary objective and the safety being the secondary. The investigators hypothesize that combined trabeculotomy-trabecuectomy with Ologen collagen matrix implant implantation in congenital glaucoma is a safer procedure and may yield better results than combined trabeculotomy-trabeculectomy approach.
"Ologen ® CM" is a biodegradable collagen matrix. To prevent episcleral fibrosis and
subconjunctival scarring thay may result in the surgical failure in filtration surgery, its
sporous matrix modulates the migrations and proliferations of fibroblasts to create a
vascular and long-lasting bleb without the adverse effects.
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 7,000 ologen
CM have been implanted worldwide during the past two years with good results and excellent
safety profile.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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