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

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910702
• Other study ID #: VISBOR-61165995
• Status: Completed
• Phase: Phase 0
• First received: May 28, 2009
• Last updated: April 29, 2013
• Start date: May 2009
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: GuangZhou WeiShiBo Biotechnology Co., ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Refractive error less than ±3D

2. Visual acuity worse than finger count

3. Ocular perforating injuries, traumatic retinal detachment, giant retinal tear with PVR, serious than grade D PVR, ocular axial length is 16 to 25mm

4. Signed the informed consent form

Exclusion Criteria:

1. Serious heart, lung, liver and kidney dysfunction

2. Serious eye inflammation

3. Silicone oil filled eyes

4. The contralateral eye is non-functional

5. Patients with diseases that the researchers consider not suitable participated in this clinical trial

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

Device:
• foldable capsular vitreous body(FCVB)
the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB) after PPV

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	GuangZhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
GuangZhou WeiShiBo Biotechnology Co., ltd	Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. Epub 2007 May 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete retinal reattach rate at the three years after implantation of the silicone-filled FCVB	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.	three years after implantation of the FCVB	Yes
Secondary	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.	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.	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	Yes