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

May 22, 2013 updated by: GuangZhou WeiShiBo Biotechnology Co., ltd

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

122

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital
        • Contact:
          • Phone Number: 010-11616669
      • Peking, Beijing, China, 100032
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Phone Number: 010-65296114
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Southwest Hospital
        • Contact:
          • Phone Number: 023-65318301
    • Guangdong
      • GuangZhou, Guangdong, China, 510000
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • The 2nd affiliated hospital of Harbin Medicinal University.
        • Contact:
          • Phone Number: 0451-86662961
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
          • Phone Number: 027-88041911
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Recruiting
        • Eye and ENT Hospital of Fudan University
        • Contact:
          • Phone Number: 021-64377134
    • Shanxi
      • Xian, Shanxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:
          • Phone Number: 029-3375015
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • The Affiliated Eye Hospital of Wenzhou Medical College
        • Contact:
          • Phone Number: 0577-88068822

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • FCVB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete retinal reattach rate at the 52 weeks after implantation of the FCVB
Time Frame: 52 weeks after implantation of the FCVB
52 weeks after implantation of the FCVB

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GuangZhou WeiShiBo Biotechnology Co., ltd

Collaborators

Sun Yat-sen University

Investigators

  • Principal Investigator: Qianying Gao, MD,Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

December 15, 2010

First Submitted That Met QC Criteria

December 15, 2010

First Posted (Estimate)

December 16, 2010

Study Record Updates

Last Update Posted (Estimate)

May 23, 2013

Last Update Submitted That Met QC Criteria

May 22, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VISBOR-61165995002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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