The Exploratory Clinical Trials for the Feasibility, Primary Safety and Efficacy of Foldable Capsular Vitreous Body
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Complete retinal reattach rate at the three years after implantation of the silicone-filled FCVB
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Complete retinal reattach rate at the three years after implantation of the silicone-filled FCVB
Time Frame: three years after implantation of the 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.
Secondary Outcomes
- 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.(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)