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

Sponsors

Lead Sponsor: GuangZhou WeiShiBo Biotechnology Co., ltd

Collaborator: Sun Yat-sen University

Source 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.

Overall Status Unknown status
Start Date September 2010
Completion Date June 2014
Primary Completion Date December 2013
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Complete retinal reattach rate at the 52 weeks after implantation of the FCVB 52 weeks after implantation of the FCVB
Secondary Outcome
Measure Time Frame
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)
Enrollment 122
Condition
Intervention

Intervention Type: Device

Intervention Name: foldable capsular vitreous body(FCVB)

Description: FCVB with silicone oil inside is tamponaded into the vitreous cavity

Arm Group Label: FCVB team

Other Name: FCVB

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Qianying Gao, MD,Ph.D Principal Investigator Zhongshan Ophthalmic Center, Sun Yat-sen University
Overall Contact

Last Name: Lian Zhou

Phone: 020-61165995

Email: v[email protected]

Location
Facility: Status: Contact:
Beijing Tongren Hospital | Beijing, Beijing, 100730, China Recruiting 010-11616669
Peking Union Medical College Hospital | Peking, Beijing, 100032, China Recruiting 010-65296114
Southwest Hospital | Chongqing, Chongqing, 400038, China Recruiting 023-65318301
Zhongshan Ophthalmic Center, Sun Yat-sen University | GuangZhou, Guangdong, 510000, China Recruiting Xia Huang 020-87330490 [email protected]
The 2nd affiliated hospital of Harbin Medicinal University. | Harbin, Heilongjiang, 150001, China Recruiting 0451-86662961
Renmin Hospital of Wuhan University | Wuhan, Hubei, 430060, China Recruiting 027-88041911
Eye and ENT Hospital of FuDan University | Shanghai, Shanghai, 200031, China Recruiting 021-64377134
XiJing Hospital | Xian, Shanxi, 710032, China Recruiting 029-3375015
The affiliated Eye Hospital of Wenzhou Medical College | Wenzhou, Zhejiang, 325027, China Recruiting 0577-88068822
Location Countries

China

Verification Date

May 2013

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: FCVB team

Type: Experimental

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

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov