Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Beijing Hospital
The purpose of this study is to determine whether the OculusGen Collagen Matrix is effective and safe to implant as an aid of glaucoma and pterygium surgeries.
Device: OculusGen Biodegradable Collagen Matrix Implant
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of the Safety and Effectiveness of the Ologen (OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery|
- the effectiveness via the reduction of IOP and the incidence of pterygium recurrence [ Time Frame: 180 day ]
- the safety via the incidence of complications and adverse events. [ Time Frame: 180 day ]
|Study Start Date:||January 2006|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that brings a certain pressure press on the top of the scleral flap which makes the dynamic balance for the aqueous system keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).