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折叠式人工玻璃体治疗严重增生性玻璃体视网膜病变伴早期眼球萎缩的临床研究 被引量:12

Evaluation of the efficacy and safety of a foldable capsular vitreous body in the treatment of severe retinal detachment
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摘要 目的探讨玻璃体切除联合折叠式人工玻璃体植入术治疗严重视网膜脱离伴早期眼球萎缩的有效性和安全性。方法前瞻性、多中心、单臂Ⅱ期临床试验。选择2011年4月至2012年7月就诊于北京同仁眼科中心门诊的严重视网膜脱离、有早期眼球萎缩特征的患者。进行常规三通道玻璃体切除术,将折叠式人工玻璃体折叠并植入玻璃体腔,囊袋内硅油填充。术后定期随访,检查视力、眼压、角膜内皮计数、彩色眼底像、相干光层析成像术、眼部B超等检查,观察视网膜复位情况及术后不良反应。对患者的基线和末次随访视力、眼压、角膜内皮计数、眼轴长度等结果进行正态性检验,符合正态分布的数据采用配对t检验进行统计学比较,不符合正态分布则采用Wilcoxon配对秩和检验。结果共纳入患者26例,其中男性23例,女性3例,年龄(37.5±11.5)岁,平均随访33个月。均单眼纳入研究,左右眼各13只。24只眼视网膜复位,眼球萎缩得以控制,4例(15.4%)患者术后视力高于术前,5例(19.2%)患者较术前无改变。术后末次随访平均眼压(14.4±3.9)mmHg(1 mmHg=0.133 kPa),高于基线眼压(12.0±6.5)mmHg,但差异无统计学意义(Z=-1.859,P=0.063),16例眼球萎缩患者患眼末次平均眼压(14.6±3.9)mmHg,显著高于患眼术前的(8.5±2.4)mmHg(t=-5.326,P<0.001),未见明显不良反应。结论折叠式人工玻璃体植入是治疗严重视网膜脱离、早期眼球萎缩的安全有效途径,可以复位视网膜,控制眼球萎缩,维持眼球外形和眼压,但术后视力无提高。 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 phaseⅡclinical 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.
作者 延艳妮 田蓓 刘倩 魏文斌 Yan Yanni;Tian Bei;Liu Qian;Wei Wenbin(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)
出处 《中华眼科杂志》 CAS CSCD 北大核心 2019年第4期259-266,共8页 Chinese Journal of Ophthalmology
基金 北京市医院管理局"登峰"人才培养计划(DFL20150201) 国家自然科学基金(81570891) 北京市自然科学基金(7151003) 北京市卫生系统高层次卫生技术人才培养计划(2014-2-003) 首都卫生发展科研专项项目(2016-1-2051.
关键词 严重视网膜脱离 早期眼球萎缩 折叠式人工玻璃体 治疗 Severe retinal detachment Early atrophy bulbi Foldable capsular vitreous body Treatment
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