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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
122
FCVB with silicone oil inside is tamponaded into the vitreous cavity
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Tongren Hospital
Beijing, Beijing Municipality, China
RECRUITINGComplete retinal reattach rate at the 52 weeks after implantation of the FCVB
Time frame: 52 weeks after implantation of the FCVB
Retinal reattach rate, Visual function,and Silicone oil change
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.
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)
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Southwest Hospital
Chongqing, Chongqing Municipality, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe 2nd affiliated hospital of Harbin Medicinal University.
Harbin, Heilongjiang, China
RECRUITINGRenmin Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGEye and ENT Hospital of FuDan University
Shanghai, Shanghai Municipality, China
RECRUITINGXiJing Hospital
Xian, Shanxi, China
RECRUITINGThe affiliated Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
RECRUITING