Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00910702
Status:
COMPLETED
Last Update Posted:
2013-04-30
First Post:
2009-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Exploratory Clinical Trials for the Feasibility, Primary Safety and Efficacy of Foldable Capsular Vitreous Body
Sponsor:
GuangZhou WeiShiBo Biotechnology Co., ltd
Organization:
Study Overview
Official Title:
The Exploratory Clinical Trials for the Feasibility, Primary Safety and Efficacy of Foldable Capsular Vitreous Body
Status:
COMPLETED
Status Verified Date:
2013-04
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 the feasibility, primary safety and efficacy of foldable capsular vitreous body (FCVB) in the treatment of retinal detachment.
Detailed Description:
Pars plana vitrectomy (PPV) has been one of the most important ophthalmic surgeries for treating a number of blinding diseases by removing and replacing the diseased vitreous body. Current clinic vitreous substitute cannot mimic the natural vitreous which is unable to regenerate after surgery. We have devised a novel foldable capsular vitreous body (FCVB) consisting of a vitreous-like capsule with a tube-valve system, and demonstrated it could finely mimic the morphology and restore main physiological function of the natural vitreous body in our previous study.
Study Oversight
Has Oversight DMC:
True
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?: