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

GuangZhou WeiShiBo Biotechnology

Status and phase: Unknown; Phase 1

Conditions: Retinal Detachment

Treatments: Device: foldable capsular vitreous body(FCVB)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01261533

VISBOR-61165995002

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, based on the multi-center clinical trial.

Full 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.

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age range from 18 to 65, Refractive error less than ±3D

2. Corrected visual acuity less than 0.05

3. ocular axial length is 16 to 25mm

4. severe retinal detachment that can not be treated by current artificial vitreous body:

   1. Severe unilateral ocular perforating injuries, compounded retinal or choroidal detachments resulted from retinal rupture or retinal choroidal hemorrhage.
   2. Severe unilateral ocular rupture injuries result in retina or choroid defect.
   3. Giant posterior scleral rupture injuries that can not be repaired.
   4. Silicone oil can't be taken out for a long time with incomplete reattachment.
   5. Participants have undergone retinal detachment surgery and silicone oil tamponade twice or more, however, retina is re-detachment after silicone oil removal.

5. Participants can understand the aim of this clinical trial and sign the informed consent form

Exclusion criteria

1. Participants have a silica gel allergy or scar diathesis
2. entophthalmia
3. uveitis
4. The contralateral eye suffered from intraocular surgery
5. uncontrollable the other eye diseases
6. Corrected visual acuity of contralateral eye less than 0.4
7. Proliferative diabetic retinopathy
8. the lens of target eye is transparent
9. Serious heart, lung, liver and kidney dysfunction
10. pregnancy, preparation for pregnancy during clinical trial and breast-feeding female
11. drug abuse or alcoholism
12. participated the other drug or medical devices clinical trial before screening of this trial
13. Any research doctors consider that the condition of participants will hinder the clinical trial--Prone to mental stress, loss control of mood, depression etc.
14. Patient adherence is so poor that study procedures can not be finished

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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122 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)