国产非球面人工晶状体植入术后安全性和视觉质量评价

Evaluation of the safety and visual quality after implantation of the domestic made aspheric intraocular lens

目的 评价国产A1-UV型可折叠一片式非球面IOL用于治疗白内障的临床安全性和有效性.方法 采用随机对照临床研究设计.选取119例（119只眼）门内障患者,通过中央动态随机系统（IWRS）分配至试验组（58例）或对照组（61例）,分别植入由爱博诺德（北京）医疗科技有限公司生产的国产非球面IOL（型号：A1-UV）或美国Alcon公司生产的非球面IOL（型号：SN60WF）于术后1～2d、1周、1个月、3个月、6个月及1年进行随访评估,记录患者的视力及裂隙灯显微镜检查结果;并于术后3个月、6个月及1年随访时进行对比敏感度检查.采用x2检验和独立样本t检验分别对计数资料和计量资料进行统计学分析.结果 共100例患者完成1年随访,其中试验组49例,对照组51例.术后两组均无患者出现严重的炎症反应及与IOL有关的其他并发症;术后1年时试验组和对照组的LogMAR最佳矫正远视力、最佳矫正近视力、裸眼远视力、裸眼近视力分别为0.04±0.11、0.11±0.17、0.13±0.20、0.35±0.19和0.07±0.15、0.15±0.20、0.18±0.23、0.41±0.21,两组之间差异无统计学意义（t=-1.39,P=0.166;t=-1.25,P=0.216;t=-1.06,P=0.292;t=-1.59,P=0.116）,术后1～2d、1周、1个月、3个月及6个月时两组视力比较差异均无统计学意义（P＞0.05）;术后3个月时试验组和对照组在明光12 c/d、18 c/d空间频率时的对比敏感度分别为1.31 ±0.36、0.86±0.41和1.15±0.40、0.65±0.44,试验组优于对照组（t=2.18,P=0.031;t=2.67,P=0.009）,其余明光、暗光空间频率的对比敏感度两组之间差异无统计学意义（P＞0.05）.结论 国产A1-UV型可折叠一片式非球面IOL用于治疗白内障临床安全性和有效性均与SN60WF非球面IOL相当,值得临床推广与应用.

Objective To evaluate the safety and efficacy of the domestic foldable one-piece aspheric intraocular lens （IOL,Model：A1-UV） for the treatment of cataract.Methods A prospective randomized controlled clinical research were conducted.One hundred and nineteen cases （119 eyes） of cataract patients were randomly assigned to the study group （58 cases） and the control group （61 cases）.The study group were implanted with the domestic made aspheric intraocular lens （Model：A1-UV） and the control group were implanted with imported aspheric intraocular lens （Model：SN60WF,Alcon Laboratories,Inc.）.The visual acuity and the slit lamp examination were evaluated 1-2 day,1 week,1 month,3 months,6 months and 1 year postoperatively.In addition,the contrast sensitivity tests were carried out 3 months,6 months and 1 year postoperatively.Data were analyzed by chi-square test and independent t-test.Results 100 patients had completed 1 year of follow-up,among which 49 cases were from the study group and 51 cases were from the control group.No severe inflammation or complications associated with intraocular lens were noted in either group within 1 year follow-up.The mean BCDVA,BCNVA,UCDVA,UCNVA（Log MAR） of the study group and the control group were 0.04±0.11,0.11±0.17,0.13±0.20,0.35± 0.19 and 0.07±0.15,0.15±0.20,0.18±0.23,0.41±0.21 at 1 year postoperatively.No statistically significant differences were noted between groups in mean BCDVA,BCNVA,UCDVA,UCNVA （t=-1.39,P=0.166;t=-1.25,P=0.216;t=-1.06,P=0.292;t=-1.59,P=0.116） at 1 year postoperatively.And there was no significant difference in visual acuity between the two groups （P〉0.05） 1-2 day,1 week,1 month,3 months and 6 months postoperatively.The difference of the contrast sensitivity between the two groups was not statistically significant （P〉0.05）,besides the contrast sensitivity of the study group was significantly better than the control group at 12c/d,18 c/d under bright light（t=2.18,P=0.031;t=2.67,P=0.009） at 3 months postoperatively.And the mean contrast sensitivity of the study group and the control group at 12c/d,18 c/d under bright light were 1.31 ± 0.36,0.86±0.41 and 1.15± 0.40,0.65± 0.44 at 3 months postoperatively.Conclusion The safety and efficacy of the domestic made foldable one-piece aspheric intraocular lens （Model：A1-UV） for the treatment of cataract is equivalent to the imported aspheric intraocular lens （Model：SN60WF）.