Preliminary Efficacy and Safety of a Silicone Oil–filled Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment

Abstract

Silicone oil-filled FCVB was shown to be effective and safe in 3 eyes as a vitreous substitute over a 12-month observation time.

A Preliminary Study to Treat Severe Endophthalmitis via a Foldable Capsular Vitreous Body with Sustained Levofloxacin Release in Rabbits

“…42 Therefore, FCVB results also may have implications in the treatment of important retinal diseases that need drug and vitreous substitutes, such as age-related macular degeneration, proliferative vitreoretinopathy, and proliferative diabetic retinopathy. This work, along with our other reports regarding the FCVB, [21][22][23][24][25][26][27][28][29][30]42 give an example of how to make the product from bench to bedside, including idea, craft, animal model, producing standard, technical reports from government, clinical trails (exploratory, multiple centers), and marketing. Based on this study, we will apply for a new clinical trial to test the combined function of FCVB.…”

“…[28][29][30] An exploratory clinical trial conducted at Zhongshan Ophthalmic Center in China suggested that an FCVB was a flexible, effective, and safe vitreous substitute over a 3-month implantation period in 11 human eyes 28 and over a 12-month implantation in 3 human eyes. 30 Currently, multiple center clinical trials are in progress to ascertain FCVB efficacy and safety as a novel vitreous substitute in nine hospitals in China. In our study, the FCVB sustainably released levofloxacin and had an effect similar to silicone oil combined with levofloxacin in suppressing microbial activity, though the silicone oil/levofloxacin group reduced inflammation in an earlier stage compared to the FCVB group.…”

“…21 As a vitreous substitute, the FCVB can be used for retinal detachments by providing a solid arc, especially in the inferior retina as well as multiple retinal detachments that silicone oil was unable to support adequately due to its low density. Meanwhile, it could avoid the disadvantages of silicone oil, including glaucoma, keratopathy, and emulsification, [27][28][29][30] and induce very little refractive shift. 22,23 Interestingly, numerous 300 nm tiny apertures were observed in the FCVB capsule, and we uncovered its potential use as a DDS for the ophthalmic drug dexamethasone sodium phosphate in the rabbit eye.…”

A Novel Artificial Vitreous Substitute - Foldable Capsular Vitreous Body

“…It can help avoid the complications induced by silicone oil, such as glaucoma, corneal keratopathy, and silicone oil emulsification during a 12-month implantation time. 53 Current data have demonstrated the theoretical advantages of using FCVBs, as mentioned above. Even if an ideal injectable material can be found, the use of FCVB is necessary to the artificial vitreous body.…”

“…At Zhongshan Ophthalmic Center, 11 patients were implanted with FCVBs filled with BSS, 52 whereas 3 patients were implanted with FCVBs filled with silicone oil. 53 Patients with serious eye inflammation, with only one eye remaining, with silicone oil-filled eyes, with serious heart, lung, liver, or kidney dysfunctions, or have other diseases that make them unsuitable for inclusion were excluded from the research. Retinal reattachments were found by B-scan in 8 (73%) of the 11 eyes at the end of the three-month treatment time; leakage of FCVB caused failure in three eyes.…”