Flexibility, Efficacy, and Safety of a Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Multi-center Exploratory Clinical Trials for the Evaluation of Flexibility, Efficacy, and Safety of a Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment

Conditions
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Retinal Detachment

Intervention / Treatment
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* Device: foldable capsular vitreous body(FCVB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age range from 18 to 65, Refractive error less than ±3D Corrected visual acuity less than 0.05 ocular axial length is 16 to 25mm severe retinal detachment that can not be treated by current artificial vitreous body: Severe unilateral ocular perforating injuries, compounded retinal or choroidal detachments resulted from retinal rupture or retinal choroidal hemorrhage. Severe unilateral ocular rupture injuries result in retina or choroid defect. Giant posterior scleral rupture injuries that can not be repaired. Silicone oil can't be taken out for a long time with incomplete reattachment. Participants have undergone retinal detachment surgery and silicone oil tamponade twice or more, however, retina is re-detachment after silicone oil removal. Participants can understand the aim of this clinical trial and sign the informed consent form Exclusion Criteria: Participants have a silica gel allergy or scar diathesis entophthalmia uveitis The contralateral eye suffered from intraocular surgery uncontrollable the other eye diseases Corrected visual acuity of contralateral eye less than 0.4 Proliferative diabetic retinopathy the lens of target eye is transparent Serious heart, lung, liver and kidney dysfunction pregnancy, preparation for pregnancy during clinical trial and breast-feeding female drug abuse or alcoholism participated the other drug or medical devices clinical trial before screening of this trial Any research doctors consider that the condition of participants will hinder the clinical trial--Prone to mental stress, loss control of mood, depression etc. Patient adherence is so poor that study procedures can not be finished

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FCVB team<br>the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB) | Device: foldable capsular vitreous body(FCVB)<br>* FCVB with silicone oil inside is tamponaded into the vitreous cavity<br>* Other names: FCVB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete retinal reattach rate at the 52 weeks after implantation of the FCVB |  | 52 weeks after implantation of the FCVB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitreous body substitute, foldable capsular vitreous body