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

Early Phase 1

Completed

• Conditions: Retinal Detachment
• Interventions: Device: foldable capsular vitreous body(FCVB)

• Registration Number: NCT00910702
• Lead Sponsor: GuangZhou WeiShiBo Biotechnology Co., ltd

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-29
• Study First Posted: 2009-06-01
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-29
• Last Update Posted: 2013-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Refractive error less than ±3D
2. Visual acuity worse than finger count
3. Ocular perforating injuries, traumatic retinal detachment, giant retinal tear with PVR, serious than grade D PVR, ocular axial length is 16 to 25mm
4. Signed the informed consent form

Exclusion Criteria

1. Serious heart, lung, liver and kidney dysfunction
2. Serious eye inflammation
3. Silicone oil filled eyes
4. The contralateral eye is non-functional
5. Patients with diseases that the researchers consider not suitable participated in this clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FCVB team	foldable capsular vitreous body(FCVB)	the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB)

Primary Outcome Measures

Name	Time	Method
Complete retinal reattach rate at the three years after implantation of the silicone-filled FCVB	three years after implantation of the FCVB	FCVBs filled with balanced salt solution (BSS) were removed from all 11 cases, however, the risk of retinal redetachment and blindness rises after earlier FCVB removal. Approved by the Sun Yat-sen University Medical Ethics Committee, the removal of the FCVB will be decided by doctors depending on the conditions of eye. The eyes implanted with the silicone oil-filled FCVB are still under observation.

Secondary Outcome Measures

Name	Time	Method
visual acuity, intraocular pressure, axial length, ocular inflammatory response, the number of corneal endothelial, anterior chamber angle and ciliary body change, morphological changes of the ocular and FCVB.	Before surgery, 3days,1 week, 2 weeks, 4 weeks, 8 weeks, 3 months, 6 months, 9 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after surgery, and 3 months after the removal of the FCVB	FCVBs filled with BSS were removed from all 11 cases, however, the risk of retinal redetachment and blindness rises after earlier FCVB removal. Approved by the Sun Yat-sen University Medical Ethics Committee, the removal of the FCVB will be decided by doctors depending on the conditions of eye. The eyes implanted with the FCVB and silicone oil are still under observation.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 GuangZhou, Guangdong, China