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

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:	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 years after implantation of the silicone-filled FCVB [ Time Frame: three years after implantation of the FCVB ] [ Designated as safety issue: Yes ]
FCVBs filled with balanced salt solution (BSS) were removed from all 11 cases, however, the risk of retinal redetachment and blindness rises after earlier FCVB removal. Approved by the Sun Yat-sen University Medical Ethics Committee, the removal of the FCVB will be decided by doctors depending on the conditions of eye. The eyes implanted with the silicone oil-filled FCVB are still under observation.

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, 6 months, 9 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after surgery, and 3 months after the removal of the FCVB ] [ Designated as safety issue: Yes ]
FCVBs filled with BSS were removed from all 11 cases, however, the risk of retinal redetachment and blindness rises after earlier FCVB removal. Approved by the Sun Yat-sen University Medical Ethics Committee, the removal of the FCVB will be decided by doctors depending on the conditions of eye. The eyes implanted with the FCVB and silicone oil are still under observation.

Enrollment:	15
Study Start Date:	May 2009
Study Completion Date:	March 2013
Primary Completion Date:	December 2012 (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 capsular vitreous body (FCVB) consisting of a vitreous-like capsule with a tube-valve system, and demonstrated it could finely mimic the morphology and restore main physiological function of the natural vitreous body in our previous study.

Eligibility

Ages Eligible for Study:	10 Years to 65 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

Locations

China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
GuangZhou, Guangdong, China, 510060

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:	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:	April 29, 2013
Health Authority:	China: 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 June 13, 2013