A Phase 3 interventional study of OculusGen Biodegradable Collagen Matrix Implant in Glaucoma and Pterygium, sponsored by Pro Top & Mediking Company Limited. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-05-22.
Sponsored by Pro Top & Mediking Company Limited · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix is effective and safe to implant as an aid of glaucoma and pterygium surgeries.
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 bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to 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).
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's planned enrollment of 60 is close to the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Pro Top & Mediking Company Limited is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1. 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
This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.
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Pro Top & Mediking Company Limited