Study on the effectiveness and safety of Foldable Capsular Vitreous Body implantation

Abstract

Background: Foldable capsular vitreous body (FCVB) was designed to treat severe retinal detachment. The aim of this study was to evaluate the efficacy and safety of the implantation of foldable capsular vitreous body in 1-year follow-up. Methods: A retrospective analysis was conducted for 20 patients with severe ocular trauma or silicone oil (SO) dependent eyes underwent vitrectomy and FCVB implantation in a 1-year follow-up. All treated eyes were peformed clinical examinations involved the visual acuity (VA) examination, Goldmann applanation tonometer, noncontact specular microscopy, fundus photography, B-Scan examination and optical coherence tomography (OCT). The groups were compared with t-test and the McNemar-Bowker test. Results: In 1-year follow-up, 20 eyes were evaluated in the study. FCVB well supported the vitreous retina in all treated eyes, and 6 treated eyes achieved retinal reattachment 12 months after FCVB implantation. There were no significant differences in VA before and after FCVB implantation (P = 1.000). In addition, the postoperative IOP markedly elevated from the preoperative IOP of 12.90 ± 7.06 mmHg to 15.15 ± 3.36 mmHg (P = 0.000017). The intraocular pressure (IOP) of 10 eyes maintained at a normal level after surgeries. The other 10 eyes showed slightly lower IOP within the acceptable level. Though two patients developed keratopathy and ocular inflammation respectively, other treated eyes were symmetric with fellow eyes showing satisfactory appearance. Moreover, there was no SO emulsification or leakage happened in the observation. Conclusions: FCVB implantation was an effective and safe treatment in the eyes with severe retinal detachment.

Foldable capsular vitreous body implantation for treatment of traumatic retinal detachment: two case reports

“…In addition, because of capsule membrane limitations, FCVBs can provide a cell barrier function, effectively avoiding SO emulsification and SO entry into the anterior chamber, as well as other complications. 14 – 16 , 18 , 22 An FCVB device is depicted in Figure 11 .…”

“…In a recent study, Zhang et al. 18 performed vitrectomy combined with FCVB implantation in 20 patients with severe ocular trauma or SO-dependent eyes, then conducted 1-year follow-up observations in all patients. The results showed that FCVBs provided good support in all treated eyes; six treated eyes achieved retinal reattachment.…”

“…The study by Zhang et al. 18 also included three pediatric patients whose IOP was restored and eye appearance was preserved after FCVB implantation, thereby demonstrating the potential for use of FCVBs as ideal vitreous substitutes to restore eyeball structure and maintain the desired appearance and esthetic characteristics.…”

“…FCVBs have been explored for clinical applications in China and several European countries; the preliminary findings have been good. 14 – 19 The main indications for FCVBs are best-corrected visual acuity (BCVA) ≤0.05; intraocular axial length of 16 to 28 mm; severe unilateral retinal detachment that is untreatable with an existing vitreous replacement, presumably caused by severe trauma with complex retinal detachment and/or choroidal detachment; irreparable large posterior scleral laceration of the unilateral eyeball; and the inability to remove SO after long-term tamponade, with incomplete retinal reattachment. Patients with no light perception should be the first choice.…”

Silicone oil in vitreoretinal surgery: indications, complications, new developments and alternative long‐term tamponade agents

“…Over the last decade, it has been used as a new intravitreal tamponade in the treatment of severe cases of RRD with very poor vision that could not be reattached completely with SO. Balanced salt solution or more preferred SO can be injected to inflate the capsule to support the shape of the vitreous cavity and by appositional closure of the retinal breaks (Gao et al 2008; Lin et al 2011; Lin et al 2012; Zhang et al 2019). Through long‐term postoperative follow‐up, the results showed that FCVB can effectively tamponade the retina with a slight elevation of IOP and visual acuity (Lin et al 2012).…”