NCT01261533

Flexibility, Efficacy, and Safety of a Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment

The Multi-center Exploratory Clinical Trials for the Evaluation of Flexibility, Efficacy, and Safety of a Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: GuangZhou WeiShiBo Biotechnology Co., ltd · Industry
• Sex: All
• Age: 18 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, based on the multi-center clinical trial.

Detailed description

Previous clinical trial have demonstrated that foldable artificial vitreous body (FCVB),with balanced salt solution (BSS) filled in 11 patients during three-months observation,or silicone oil filled in 4 patients during a six-month observation respectively, can be transplanted into the vitreous body easily, and performances good safety and efficacy in the treatment of severe retinal detachment. Current multi-center clinical trial was to determine the feasibility, primary safety and efficacy of FCVB with silicone oil filled in the treatment of retinal detachment in 120 patients.

Conditions

• Retinal Detachment

Interventions

Type	Name	Description
DEVICE	foldable capsular vitreous body(FCVB)	FCVB with silicone oil inside is tamponaded into the vitreous cavity

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-12-01
• Completion: 2014-06-01
• First posted: 2010-12-16
• Last updated: 2013-05-23

Locations

9 sites across 1 country: China