Flexibility, Efficacy, and Safety of a Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment
NCT ID: NCT01261533
Last Updated: 2013-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
122 participants
INTERVENTIONAL
2010-09-30
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Exploratory Clinical Trials for the Feasibility, Primary Safety and Efficacy of Foldable Capsular Vitreous Body
NCT00910702
Multi-center Clinical Observation of FCVB in Guangdong Province
NCT03908515
Treating Rhegmatogenous Retinal Detachment by Foldable Capsular Buckle
NCT04571788
Foldable Capsular Scleral Buckling Versus Vitrectomy in Medium-complex Rhegmatogenous Retinal Detachment Treatment
NCT06610786
Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment
NCT04518696
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FCVB team
the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB)
foldable capsular vitreous body(FCVB)
FCVB with silicone oil inside is tamponaded into the vitreous cavity
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
foldable capsular vitreous body(FCVB)
FCVB with silicone oil inside is tamponaded into the vitreous cavity
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-sen University
OTHER
GuangZhou WeiShiBo Biotechnology Co., ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Qianying Gao, MD,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Southwest Hospital
Chongqing, Chongqing Municipality, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
The 2nd affiliated hospital of Harbin Medicinal University.
Harbin, Heilongjiang, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Eye and ENT Hospital of FuDan University
Shanghai, Shanghai Municipality, China
XiJing Hospital
Xian, Shanxi, China
The affiliated Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Gao Q, Mou S, Ge J, To CH, Hui Y, Liu A, Wang Z, Long C, Tan J. A new strategy to replace the natural vitreous by a novel capsular artificial vitreous body with pressure-control valve. Eye (Lond). 2008 Mar;22(3):461-8. doi: 10.1038/sj.eye.6702875. Epub 2007 May 25.
Gao Q, Chen X, Ge J, Liu Y, Jiang Z, Lin Z, Liu Y. Refractive shifts in four selected artificial vitreous substitutes based on Gullstrand-Emsley and Liou-Brennan schematic eyes. Invest Ophthalmol Vis Sci. 2009 Jul;50(7):3529-34. doi: 10.1167/iovs.08-2802. Epub 2009 Mar 5.
Liu Y, Jiang Z, Gao Q, Ge J, Chen J, Cao X, Shen Q, Ma P. Technical standards of a foldable capsular vitreous body in terms of mechanical, optical, and biocompatible properties. Artif Organs. 2010 Oct;34(10):836-45. doi: 10.1111/j.1525-1594.2010.01006.x.
Liu Y, Ke Q, Chen J, Wang Z, Xie Z, Jiang Z, Ge J, Gao Q. Sustained mechanical release of dexamethasone sodium phosphate from a foldable capsular vitreous body. Invest Ophthalmol Vis Sci. 2010 Mar;51(3):1636-42. doi: 10.1167/iovs.09-4134. Epub 2009 Oct 15.
Lin X, Ge J, Gao Q, Wang Z, Long C, He L, Liu Y, Jiang Z. Evaluation of the flexibility, efficacy, and safety of a foldable capsular vitreous body in the treatment of severe retinal detachment. Invest Ophthalmol Vis Sci. 2011 Jan 21;52(1):374-81. doi: 10.1167/iovs.10-5869.
Zhang R, Wang T, Xie C, Lin X, Jiang Z, Wang Z, Liu Y, Luo Y, Long C, He L, Wang P, Gao Q. Evaluation of supporting role of a foldable capsular vitreous body with magnetic resonance imaging in the treatment of severe retinal detachment in human eyes. Eye (Lond). 2011 Jun;25(6):794-802. doi: 10.1038/eye.2011.61. Epub 2011 Mar 18.
Wang P, Gao Q, Jiang Z, Lin J, Liu Y, Chen J, Zhou L, Li H, Yang Q, Wang T. Biocompatibility and retinal support of a foldable capsular vitreous body injected with saline or silicone oil implanted in rabbit eyes. Clin Exp Ophthalmol. 2012 Jan-Feb;40(1):e67-75. doi: 10.1111/j.1442-9071.2011.02664.x. Epub 2011 Oct 20.
Lin X, Wang Z, Jiang Z, Long C, Liu Y, Wang P, Jin C, Yi C, Gao Q. Preliminary efficacy and safety of a silicone oil-filled foldable capsular vitreous body in the treatment of severe retinal detachment. Retina. 2012 Apr;32(4):729-41. doi: 10.1097/IAE.0b013e31822b1f80.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VISBOR-61165995002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.