Evaluation of supporting role of a foldable capsular vitreous body with magnetic resonance imaging in the treatment of severe retinal detachment in human eyes

Abstract

Purpose To determine the supporting role of a novel foldable capsular vitreous body (FCVB) with magnetic resonance imaging (MRI) in the treatment of severe retinal detachment in human eyes. Methods The study examined nine eyes of nine patients. Among the nine eyes, five had suffered penetrating injuries while four had suffered contusions of the eyeball involving large defects of the retina or choroids. A standard three-port pars plana vitrectomy was performed, FCVB was triple-folded and sent into the vitreous cavity; balanced salt solution (BSS) was injected into the capsule to support the retina. Three cardinal axes of nine eyes were examined using MRI at baseline and at the 3-month follow up. Results MRI revealed that the signal intensity of the FCVB was similar to the normal vitreous body, with low-signal intensity on T1-weighted image and high-signal intensity on T2-weighted image. In three pre-operative silicone oil-or heavy silicone oil-filled eyes, FCVBs were not fully inflated, and eyeball deformation was observed in one eye. Shifts of three cardinal axes of three eyes (horizontal, anteroposterior, and vertical) according to MRI, were À4.33, À4.67, and À2.67 mm. In the remaining six eyes, FCVBs were well distributed in the vitreous cavity and evenly supported the retina; the cardinal axes of the eyes were similar to pre-operation. Shifts of three cardinal axes of six eyes were À0.34, À0.34, and À0.34 mm. In a total of nine eyes, shifts of three cardinal axes were À1.67, À1.77, and À1.11 mm. Statistically significant difference showed only between the horizontal axis of nine eyes pre-operatively and post-operativelyConclusion This study demonstrated the effectiveness of MRI to monitor the supporting role of an FCVB in the treatment of severe retinal detachment in human eyes.

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.…”

“…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.…”

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

“…We also used magnetic resonance imaging to monitor the support of the FCVB and found that FCVB can fully fill the vitreous cavity. 23 Therefore, FCVB provides us with a new therapeutic theory and product for severe RD.…”

Timing and Outcomes of Vitreoretinal Surgery after Traumatic Retinal Detachment

“…Attachment of the macula at presentation was associated with an improved visual outcome [9, 10]. Developing endophthalmitis conferred an inferior visual outcome in one study [18] but was not shown to have the same effect in another [14]. Recurrent retinal detachment predicted a worse visual outcome [10], as did total RD on presentation, retention of silicone oil in the eye, and development of PVR [14].…”