国产散光矫正型人工晶状体植入术后5年以上的安全性和有效性评价  

Safety and efficacy of toric intraocular lens implantation for more than 5 years

作　　者：宋旭东 郝燕生[2] 鲍永珍[3] 李朝辉[4] 张红 俞阿勇 赵梅生[7] 黄钰森 方军[9] 刘洋[9] 孙岩秀[2] 王宁利 Song Xudong;Hao Yansheng;Bao Yongzhen;Li Zhaohui;Zhang Hong;Yu Ayong;Zhao Meisheng;Huang Yusen;Fang Jun;Liu Yang;Sun Yanxiu;Wang Ningli(Beijing Tongren Eye Center,Beijing Tongren Hospital,Capital Medical University,Beijing Institute of Ophthalmology,Beijing Key Laboratory of Ophthalmology&Visual Sciences,Beijing 100730,China;Department of Ophthalmology,Peking University Third Hospital,Beijing Key Laboratory of Restoration of Damaged Ocular Nerve,Beijing 100191,China;Department of Ophthalmology,Peking University People′s Hospital,Eye Diseases and Optometry Institute,Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases,College of Optometry,Peking University Health Science Center,Beijing 100044,China;Department of Ophthalmology,Chinese PLA General Hospital,Beijing 100853,China;Tianjin Medical University Eye Hospital,Eye Institute and School of Optometry,Tianjin Branch of National Clinical Research Center for Ocular Disease,Tianjin Key Laboratory of Retinal Functions and Diseases,Tianjin 300384,China;Department of Cataract,Eye Hospital of Wenzhou Medical University,Wenzhou 325027,China;Department of Cataract,the Second Hospital of Jilin University,Changchun 130041,China;Eye Institute of Shandong First Medical University,Qingdao Eye Hospital of Shandong First Medical University,State Key Laboratory Cultivation Base,Shandong Provincial Key Laboratory of Ophthalmology,School of Ophthalmology,Shandong First Medical University,Qingdao 266071,China;Department of Ophthalmology,Daqing Oilfield General Hospital,Daqing 163001,China)

机构地区：[1]首都医科大学附属北京同仁医院北京同仁眼科中心、北京市眼科研究所、北京市眼科学与视觉科学重点实验室,北京100730 [2]北京大学第三医院眼科、眼部神经损伤的重建保护与康复北京市重点实验室,北京100191 [3]北京大学人民医院眼科、眼病与视光医学研究所、视网膜脉络膜疾病诊治研究北京市重点实验室、北京大学医学部眼视光学院,北京100044 [4]解放军总医院眼科医学部,北京100853 [5]天津医科大学眼科医院、天津医科大学眼视光学院、天津医科大学眼科研究所、国家眼耳鼻喉疾病临床医学研究中心天津市分中心、天津市视网膜功能与疾病重点实验室,天津300384 [6]温州医科大学附属眼视光医院白内障临床中心,温州325027 [7]吉林大学第二医院白内障科,长春130041 [8]山东第一医科大学附属眼科研究所、山东第一医科大学附属青岛眼科医院、山东省眼科学重点实验室-省部共建国家重点实验室培育基地、山东第一医科大学眼科学院,青岛266071 [9]大庆油田总医院眼科,大庆163001

出　　处：《中华眼科杂志》2023年第2期118-128,共11页Chinese Journal of Ophthalmology

摘　　要：目的评价国产散光矫正型(Toric)人工晶状体(IOL)植入术后5年以上的临床安全性和有效性。方法前瞻性队列研究。对2014年5月至2016年5月在9家医院通过中央动态随机系统分组并完成1年随访的患者(单眼入组)进行延续观察,试验组和对照组分别植入爱博诺德(北京)医疗科技股份有限公司和美国爱尔康公司的Toric IOL。记录术前、术后1 d、6个月、1年、5年的视力、IOL旋转度数、术后并发症、眼压、主观评价等情况。主要统计学分析方法包括Mann-WhitneyU检验、独立样本t检验、Wilcoxon符号秩检验、配对样本t检验、卡方检验或Fisher确切检验。结果45例(试验组26例、对照组19例)患者完成5年延续观察,男性17例,女性28例;年龄(72.07±10.67)岁;术后随访(5.39±0.47)年。术后5年,试验组和对照组的裸眼远视力(0.20±0.26、0.16±0.13,t=0.17,P=0.752)、最佳矫正远视力[0.00(0.00,0.20)、0.05±0.10,U=188.00,P=0.880]、裸眼近视力[0.50(0.20,0.60)、0.42±0.20,U=158.00,P=0.559]、最佳矫正近视力(0.13±0.16、0.17±0.23,t=0.14,P=0.645)之间的差异均无统计学意义,且相对基线均有提高(均P<0.05)。术后5年,试验组和对照组的客观验光柱镜度数[(-0.67±0.85)、(-0.73±1.08)D;t=-1.50,P=0.149;t=-1.68,P=0.118]、主觉验光柱镜度数[-0.50(-1.00,0.00)、(0.69±0.87)D;U=36.50,P<0.001;t=6.91,P<0.001]相对于术前角膜散光[试验组(1.27±0.49)D,对照组(1.34±0.82)D]均有显著降低。术后5年,眼压、视觉不良症状主观评价、视远脱镜情况和总体满意度评价的组间差异均无统计学意义(均P>0.05)。旋转稳定性方面,试验组和对照组术后5年的IOL旋转度数分别为3.0°(1.0°,6.0°)、4.0°(2.0°,6.0°),差异无统计学意义(U=185.50,P=0.574)。术后5年,试验组和对照组分别有7例和4例发生后发性白内障;试验组未见IOL闪辉,对照组则有5例(5/19)。结论国产Toric IOL植入术后5年矫正白内障伴有规则角膜散光的远�Objective To evaluate the clinical safety and efficacy of toric intraocular lens(IOL)implantation for more than 5 years.Methods This study was a prospective cohort study in which subjects were continuously observed over a two-year period(May 2014 to May 2016)in nine hospitals.The study randomly assigned subjects to two groups using a central dynamic randomization system:the study group,which received Proming®IQ toric IOL implants,and the control group,which received AcrySof®IQ toric IOL implants.The subjects completed a one-year follow-up,during which various measures were taken and evaluated,including visual acuity,IOL rotation,postoperative complications,intraocular pressure,and subjective evaluation(preoperatively and at 1 day,6 months,1 year,and 5 years post-surgery).The main statistical analysis methods include the Mann-Whitney U test,independent sample t-test,Wilcoxon signed rank test,paired sample t-test,chi-square test,and Fisher′s exact test.Results A total of 45 eyes(26 in the study group and 19 in the control group)completed the five-year continuous observation period.The mean age of the subjects was(72.07±10.67)years and the mean interval from surgery to the last visit was(5.39±0.47)years.After five years,there were no significant differences in uncorrected distance visual acuity(0.20±0.26 vs.0.16±0.13,t=0.17,P=0.752),best corrected distance visual acuity[0.00(0.00,0.20)vs.0.05±0.10,U=188.00,P=0.880],uncorrected near visual acuity[0.50(0.20,0.60)vs.0.42±0.20,t=0.35,P=0.857],and best corrected near visual acuity(0.13±0.16 vs.0.17±0.23,U=161.00,P=0.884)between the two groups.However,all measures improved significantly from baseline levels in both groups(all P<0.05).Five years after surgery,no matter objective refraction[(-0.67±0.85)D vs.(-0.73±1.08)D]or subjective refraction[-0.50(-1.00,0.00)D vs.(0.69±0.87)D],the degree of cylindrical degree is significantly lower than preoperative corneal astigmatism[(1.27±0.49)D vs.(1.34±0.82)D,all P<0.001].In addition,there were no significant diffe

关 键 词：晶体 人工 散光 视敏度 旋转 有效性研究(主题) 

分 类 号：R779.6[医药卫生—眼科]