The Exploratory Clinical Trials for the Feasibility, Primary Safety and Efficacy of Foldable Capsular Vitreous Body - Full Text View

Sponsor:	GuangZhou WeiShiBo Biotechnology Co., ltd
Collaborator:	Sun Yat-sen University
Information provided by:	GuangZhou WeiShiBo Biotechnology Co., ltd
ClinicalTrials.gov Identifier:	NCT00910702

Purpose

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.

Condition	Intervention	Phase
Retinal Detachment	Device: foldable capsular vitreous body(FCVB)	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Exploratory Clinical Trials for the Feasibility, Primary Safety and Efficacy of Foldable Capsular Vitreous Body

Further study details as provided by GuangZhou WeiShiBo Biotechnology Co., ltd:

Primary Outcome Measures:

Complete retinal reattach rate at the three months after removal of the FCVB. [ Time Frame: three months after removal of the FCVB ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

visual acuity, intraocular pressure, axial length, ocular inflammatory response, the number of corneal endothelial, anterior chamber angle and ciliary body change, morphological changes of the ocular and FCVB. [ Time Frame: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 8 weeks, 3 months after surgery, and 3 months after the removal of the FCVB ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	May 2009
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: FCVB team the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB)	Device: foldable capsular vitreous body(FCVB) the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB) after PPV Other Name: FCVB

Detailed Description:

Pars plana vitrectomy (PPV) has been one of the most important ophthalmic surgeries for treating a number of blinding diseases by removing and replacing the diseased vitreous body. Current clinic vitreous substitute cannot mimic the natural vitreous which is unable to regenerate after surgery. We have devised a novel foldable artificial vitreous body (FCVB) consisting of a vitreous-like capsule with a silicone tube-valve system, and previous study demonstrated it could finely mimic the morphology and restore main physiological function of the natural vitreous body.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Refractive error less than ±3D
Visual acuity worse than finger count
Ocular perforating injuries, traumatic retinal detachment, giant retinal tear with PVR, serious than grade D PVR, ocular axial length is 16 to 25mm
Signed the informed consent form

Exclusion Criteria:

Serious heart, lung, liver and kidney dysfunction
Serious eye inflammation
Silicone oil filled eyes
The contralateral eye is non-functional
Patients with diseases that the researchers consider not suitable participated in this clinical trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910702

Contacts

Contact: Zhou Hu

020-61165995

visbor@hotmail.com

Locations

China, GuangDong
Zhongshan Ophthalmic Center, Sun Yat-sen University	Recruiting
GuangZhou, GuangDong, China, 510060
Contact: Zhou Hu 020-611659595 visbor@hotmail.com

Sponsors and Collaborators

GuangZhou WeiShiBo Biotechnology Co., ltd

Sun Yat-sen University

Investigators

Principal Investigator:

Qianying Gao, MD,Ph.D

Zhongshan Ophthalmic Center, Sun Yat-sen University

More Information

Publications:

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. 2008 Mar;22(3):461-8. 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 Mar 5; [Epub ahead of print]

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Print 2011.

Responsible Party:	ZhouHu, GuangZhou WeiShiBo Biotechnology Co., Ltd
ClinicalTrials.gov Identifier:	NCT00910702 History of Changes
Other Study ID Numbers:	VISBOR-61165995
Study First Received:	May 28, 2009
Last Updated:	May 29, 2009
Health Authority:	China: State Food and Drug Administration

Keywords provided by GuangZhou WeiShiBo Biotechnology Co., ltd:

retinal detachment, vitreous body substitute

Additional relevant MeSH terms:

Retinal Detachment
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012