维视安®CTR型囊袋张力环植入术后5年及以上的安全性和有效性评价  

Safety and efficacy evaluation of CTR model capsular tension ring implanted for more than 5 years

作　　者：陈伟蓉[1] 叶剑 俞阿勇 Chen Weirong;Ye Jian;Yu Ayong(Zhongshan Ophthalmic Center,Sun Yat-sen University,Guangzhou 510060,China;Department of Ophthalmology,Army Medical Center of PLA,Army Characteristic Medical Center(Daping Hospital),Chongqing 400042,China;Eye Hospital,Wenzhou Medical University,Wenzhou 325027,China)

机构地区：[1]中山大学中山眼科中心,广州510060 [2]陆军军医大学陆军特色医学中心眼科(大坪医院),重庆400042 [3]温州医科大学附属眼视光医院,325027

出　　处：《眼科》2022年第6期423-428,共6页Ophthalmology in China

摘　　要：目的评价维视安®CTR型囊袋张力环植入术后5年及以上的安全性和有效性。设计前瞻性队列研究。研究对象36例受试者完成5年以上延续观察,试验组和对照组各18例。临床研究机构为中山大学中山眼科中心、陆军军医大学陆军特色医学中心眼科(大坪医院)、温州医科大学附属眼视光医院3家医院。方法对前期实施晶状体摘除联合囊袋张力环及IOL植入术并完成术后1年随访的受试者(单眼入组)进行5年以上的延续观察。前期已将受试者随机分为两组,试验组植入维视安®CTR型囊袋张力环,对照组植入TENSIOBAG型囊袋张力环。主要指标裸眼远视力(LogMAR)、最佳矫正远视力(LogMAR)、屈光度、眼压、角膜内皮细胞密度、裂隙灯检查结果、视觉不良症状主观评价结果、远视脱镜率及总体满意度。结果基线时,两组受试者基本资料、眼科专科检查等方面的差异均无统计学意义。术后不同访视时间点,裸眼远视力、最佳矫正远视力、客观屈光度测量值两组组间比较均无统计学差异(P均>0.05)。术后5年及以上时,裸眼远视力:试验组由术前0.49±0.41改善至0.20±0.20,对照组由术前0.52±0.51改善至0.32±0.33;试验组裸眼远视力达到0.30及更佳的比例为88.89%,对照组为72.22%;最佳矫正远视力:试验组由术前0.44±0.37改善至0.09±0.12,对照组由术前0.34±0.23改善至0.10±0.21;屈光度:试验组由术前(-3.52±8.70)D改善至(-0.70±2.05)D,对照组由术前(-4.49±7.14)D改善至(-0.51±1.32)D。试验组视力和屈光度与其他术后时间点比较均无显著差异,而对照组出现一定程度波动;两组眼压比较无显著性差异(P均>0.05),与基线期比较均无显著性差异(P均>0.05);两组角膜内皮细胞密度比较无显著性差异(P=0.128)。两组受试者均未出现IOL偏移、囊袋位置异常及皱缩的情况;裂隙灯检查、视觉不良症状主观评价、脱镜情况和总体满意度两组组�Objective To evaluate the 5-year or longer clinical safety and efficacy of CTR model capsular tension ring implantation.Design Prospective cohort study.Participants 36 subjects completed 5-year continuous observation,including 18 subjects in the study group and 18 subjects in the control group.The clinical research centers were Zhongshan Ophthalmic Center,Sun Yat-sen University;Department of Ophthalmology,Army Medical Center of PLA,Army Characteristic Medical Center(Daping Hospital)and Eye Hospital;Wenzhou Medical University.Methods The subjects who underwent lens extraction combined with capsular tension ring and intraocular lens implantation and completed 1 year follow-up(monocular enrollment)were observed for more than 5 years.In the early stage,the subjects were randomly divided into two groups,the subjects in study group were implanted with the CTR model capsular tension ring and the subjects in control group were implanted with the TENSIOBAG model capsular tension ring.Main Outcome Measures Uncorrected distance visual acuity(UDVA)(LogMAR),best-corrected distance visual acuity(BCDVA)(LogMAR),spherical equivalent(SE),intraocular pressure(IOP),corneal endothelial cell density,slit lamp examination results,subjective visual evaluation results,hyperopia out of lens rate and overall satisfaction.Results There were no significant differences between the two groups in terms of baseline basic data and ophthalmologic examinations,balanced and comparable.At different visit time points after operation,there was no significant difference in UDVA,BCDVA,and objective SE between the two groups(all P>0.05).At 5 years after operation,UDVA was improved from 0.49±0.41 to 0.20±0.20 in the study group and from 0.52±0.51 to 0.32±0.33 in the control group.The UDVA reached 0.30 or better ratio was 88.89%in the study group,and was 72.22%in the control group;BCDVA was from 0.44±0.37 to 0.09±0.12 in the study group and from 0.34±0.23 to 0.10±0.21 in the control group;the objective SE was from-3.52±8.70 D to-0.70±2.05 D in th

关 键 词：囊袋张力环 白内障 

分 类 号：R779.6[医药卫生—眼科]