Yan Y N, Tian B, Liu Q, Wei W B
Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology & Visual Sciences Key Laboratory, Beijing Key Laboratory of intraocular Tumor Diagnosis and Treatment, Beijing 100730, China.
Zhonghua Yan Ke Za Zhi. 2019 Apr 11;55(4):259-266. doi: 10.3760/cma.j.issn.0412-4081.2019.04.007.
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. 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. 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 (-1.859, 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] (-5.326, 0.001). No obvious adverse reactions were observed. 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. .
探讨玻璃体切除术联合折叠式囊状玻璃体植入术治疗人眼严重视网膜脱离伴早期眼球萎缩的疗效及安全性。本研究为前瞻性、多中心、单臂Ⅱ期临床试验。纳入2011年4月至2012年7月在北京同仁眼科中心就诊的严重视网膜脱离伴早期眼球萎缩患者。行标准三通道平坦部玻璃体切除术，将折叠式囊状玻璃体折叠后送入玻璃体腔；向囊内注入硅油。术后进行视力、眼压测量，角膜内皮细胞计数，彩色眼底照相，光学相干断层扫描及眼部超声检查，观察视网膜复位及不良反应情况。采用Wilcoxon符号秩和检验比较术前及术后视力、眼压及角膜内皮细胞计数。共纳入26例患者，其中男性23例，女性3例。年龄为（37.5±11.5）岁，平均随访33个月。每位患者仅纳入一只眼（左眼13只，右眼13只）。24只眼中均见视网膜复位，所有患者眼球萎缩均得到控制。4例患者（15.4%）视力提高，5例患者（19.2%）视力无变化。末次随访时平均眼压为（14.4±3.9）mmHg（1 mmHg = 0.133 kPa），高于术前眼压（12.0±6.5）mmHg，但差异无统计学意义（-1.859，0.063）。基线时存在眼球萎缩的16例患者，末次随访眼压（14.6±3.9）mmHg明显高于术前眼压（8.5±2.4）mmHg（-5.326，0.001）。未观察到明显不良反应。折叠式囊状玻璃体植入术是治疗严重视网膜脱离伴早期眼球萎缩的有效方法。它有助于视网膜复位，控制眼球萎缩，维持眼球形态及眼压，然而视力改善有限。
