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

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.

Detailed Description
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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.

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

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: 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

Ages Eligible for Study
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Minimum Age: 10 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>* the vitreous cavity is tamponaded with the foldable capsular vitreous body (FCVB) after PPV<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 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal detachment, vitreous body substitute