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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01261533
Recruitment Status : Unknown
Verified May 2013 by GuangZhou WeiShiBo Biotechnology Co., ltd.
Recruitment status was:  Recruiting
First Posted : December 16, 2010
Last Update Posted : May 23, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Retinal Detachment Device: foldable capsular vitreous body(FCVB) Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: FCVB team
the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB)
Device: foldable capsular vitreous body(FCVB)
FCVB with silicone oil inside is tamponaded into the vitreous cavity
Other Name: FCVB

Outcome Measures

Primary Outcome Measures :
  1. Complete retinal reattach rate at the 52 weeks after implantation of the FCVB [ Time Frame: 52 weeks after implantation of the FCVB ]

Secondary Outcome Measures :
  1. Retinal reattach rate, Visual function,and Silicone oil change [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261533

Contact: Lian Zhou 020-61165995 vesber_zl@163.com

China, Beijing
Beijing Tongren Hospital Recruiting
Beijing, Beijing, China, 100730
Contact    010-11616669      
Peking Union Medical College Hospital Recruiting
Peking, Beijing, China, 100032
Contact    010-65296114      
China, Chongqing
Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400038
Contact    023-65318301      
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University Recruiting
GuangZhou, Guangdong, China, 510000
Contact: Xia Huang    020-87330490    gaoketizu@163.com   
China, Heilongjiang
The 2nd affiliated hospital of Harbin Medicinal University. Recruiting
Harbin, Heilongjiang, China, 150001
Contact    0451-86662961      
China, Hubei
Renmin Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430060
Contact    027-88041911      
China, Shanghai
Eye and ENT Hospital of FuDan University Recruiting
Shanghai, Shanghai, China, 200031
Contact    021-64377134      
China, Shanxi
XiJing Hospital Recruiting
Xian, Shanxi, China, 710032
Contact    029-3375015      
China, Zhejiang
The affiliated Eye Hospital of Wenzhou Medical College Recruiting
Wenzhou, Zhejiang, China, 325027
Contact    0577-88068822      
Sponsors and Collaborators
GuangZhou WeiShiBo Biotechnology Co., ltd
Sun Yat-sen University
Principal Investigator: Qianying Gao, MD,Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University
More Information


Responsible Party: GuangZhou WeiShiBo Biotechnology Co., ltd
ClinicalTrials.gov Identifier: NCT01261533     History of Changes
Other Study ID Numbers: VISBOR-61165995002
First Posted: December 16, 2010    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013

Keywords provided by GuangZhou WeiShiBo Biotechnology Co., ltd:
vitreous body substitute
foldable capsular vitreous body

Additional relevant MeSH terms:
Dissociative Disorders
Retinal Detachment
Mental Disorders
Retinal Diseases
Eye Diseases