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[Evaluation of the efficacy and safety of a foldable capsular vitreous body in the treatment of severe retinal detachment].

Objective: To determine the efficacy and safety of vitrectomy combined with implantation of a foldable capsular vitreous body in the treatment of severe retinal detachment with early ocular atrophy in human eyes. Methods: This study was a prospective, multicenter, and one-arm phase Ⅱ clinical trial. Patients with severe retinal detachment and early eyeball atrophy attending Beijing Tongren Eye Center from April 2011 to July 2012 were included. A standard three-port pars plana vitrectomy was performed, and a foldable capsular vitreous body was folded and sent into the vitreous cavity; silicone oil was injected into the capsule. Measurement of visual acuity and intraocular pressure, corneal endothelium count, color fundus photography, optical coherence tomography, and ocular ultrasonography were performed to observe retinal reattachment and adverse reactions after surgery. Wilcoxon signed rank test was performed to compare the baseline and postoperative visual acuity, intraocular pressure and corneal endothelium count. Results: A total of 26 patients were enrolled, including 23 males and 3 females. The age was (37.5±11.5) years, with an average follow-up of 33 months. For each patient, only the left or right eye was included (13 left eyes and 13 right eyes). Retinal reattachment was found in all 24 eyes, and the eyeball atrophy was controlled in all patients. Visual acuity was improved in 4 patients (15.4%) and unchanged in 5 patients (19.2%). The mean intraocular pressure [(14.4±3.9) mmHg(1 mmHg=0.133 kPa)] at the last follow-up was higher than the baseline intraocular pressure [(12.0±6.5) mmHg], but the difference was not statistically significant (Z=-1.859, P=0.063). For the 16 patients with ocular atrophy at baseline, the last follow-up intraocular pressure [(14.6±3.9) mmHg] was significantly higher than the preoperative intraocular pressure [(8.5±2.4) mmHg] (t=-5.326, P<0.001). No obvious adverse reactions were observed. Conclusions: Implantation of a foldable capsular vitreous body is an effective way to treat severe retinal detachment with early eyeball atrophy. It can help to reattach the retina, control eyeball atrophy, maintain the eye shape and intraocular pressure, while visual acuity improvement is limited. (Chin J Ophthalmol, 2019, 55: 259-266).