Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320957
Status:
COMPLETED
Last Update Posted:
2008-05-26
First Post:
2006-05-01
Brief Title:
Ologen OculusGen-Glaucoma and Pterygium Historical Control Study in China Zhong-Shan Hospital
Sponsor:
Pro Top Mediking Company Limited
Organization:
Pro Top Mediking Company Limited
Study Overview
Official Title:
Study of the Safety and Effectiveness of the Ologen OculusGen Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery
Detailed Description:
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 Tenons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None