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

GuangZhou WeiShiBo Biotechnology

Status and phase: Completed; Early Phase 1

Conditions: Retinal Detachment

Treatments: Device: foldable capsular vitreous body(FCVB)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00910702

VISBOR-61165995

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 10 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

FCVB team

Experimental group

Description:

the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB)

Treatment:

Device: foldable capsular vitreous body(FCVB)