A pilot clinical study of complex rhegmatogenous retinal detachment treatment via foldable capsular buckle scleral buckling

Abstract

Background To evaluate the feasibility of and identify problems in treating complex rhegmatogenous retinal detachment using foldable capsular buckle scleral buckling. Methods This prospective clinical study enrolled five patients with complex rhegmatogenous retinal detachment treated with foldable capsular buckle scleral buckling at the 988th Hospital of People’s Liberation Army Joint Logistic Force, China. During the 24-week follow-up period, the patients underwent measurements of their best-corrected visual acuity, slit-lamp examination, indirect ophthalmoscopy, and visual field testing. Additionally, B-ultrasound and fundus photography of the patients’ retinal reattachments helped evaluate the treatment’s post-surgery efficacy. We determined the safety of foldable capsular buckle scleral buckling based on infection, eye pain, diplopia, elevated intraocular pressure, and other postoperative severe complications. Results All five patients’ complex rhegmatogenous retinal detachments were successfully treated and evaluated via B-ultrasound and fundus photography after surgery. Visual acuity was enhanced in four patients 24 weeks after surgery, while the remaining patients developed diplopia after surgery. No other complications were observed. Conclusion This pilot study preliminarily determined that foldable capsular buckle scleral buckling is feasible for efficient and safe treatment of complex rhegmatogenous retinal detachment. These results support this surgery as a potential and novel alternative to current extraocular procedures for treating complex rhegmatogenous retinal detachment. Trial registration The prospective observational clinical study protocol was approved by the Institutional Review Board and Ethics Committee and registered at the clinical research center in the 988th Hospital of People’s Liberation Army Joint Logistic Force, China (9,882,019,000).

Efficacy of scleral buckling for the treatment of rhegmatogenous retinal detachment using a novel foldable capsular buckle

“…However, retinal redetachment occurred in 2 patients, and they needed secondary surgery. Previous studies have reported that the single-operation anatomical success rate of balloon-assisted scleral buckling for RRD ranges from 80% to 100% [1,18,20,22,24,[26][27] . Factors contributing to the failure of the procedure include inadequate buckling, undetected breaks, new breaks discovered after surgery, choroidal detachment, balloon prolapse, another break, inadequate adhesion, break caused by vitreous retraction, proliferative vitreoretinopathy (PVR), etc [19] .…”

“…The material of FCB is the same as that of FCVB, which is made of FDA-approved pure silicone that has been safely used in the human body for more than 20y with good biocompatibility. The FCB consists of a very thin lumen-shaped balloon and a tube-valve system [24][25] (Figure 1A). In most selected cases, FCB can be used without fixation sutures, cryotherapy, drainage, or traction sutures for external ocular muscles.…”