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

Phase 1

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

• Registration Number: NCT01261533
• 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, 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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-22
• Last Update Posted: 2013-05-23
• Primary Completion: 2013-12
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

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

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 52 weeks after implantation of the FCVB	52 weeks after implantation of the FCVB

Secondary Outcome Measures

Name	Time	Method
Retinal reattach rate, Visual function，and Silicone oil change	Before surgery, 3days,1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks after FCVB implantation surgery (If patients ask for the delay of removal of FCVB, the patients must received a review every three months)	visual acuity, intraocular pressure, axial length, ocular inflammatory response, the number of corneal endothelial, emulsification rate of silicone oil, migration of silicone oil droplets into the anterior, chamber, anterior chamber angle and ciliary body change, morphological changes of the ocular and FCVB.

Trial Locations

Locations (9)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China

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

The 2nd affiliated hospital of Harbin Medicinal University.; 🇨🇳 Harbin, Heilongjiang, China

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Peking, Beijing, China

Eye and ENT Hospital of FuDan University; 🇨🇳 Shanghai, Shanghai, China

XiJing Hospital; 🇨🇳 Xian, Shanxi, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

The affiliated Eye Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China