NCT00910702

The Exploratory Clinical Trials for the Feasibility, Primary Safety and Efficacy of Foldable Capsular Vitreous Body

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: GuangZhou WeiShiBo Biotechnology Co., ltd · Industry
• Sex: All
• Age: 10 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Retinal Detachment

Interventions

Type	Name	Description
DEVICE	foldable capsular vitreous body(FCVB)	the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB) after PPV

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2009-06-01
• Last updated: 2013-04-30

Locations

1 site across 1 country: China