Objective: To evaluate the clinical safety and efficacy of A1-UV aspheric intraocular lens (IOL) implantation over the postoperative 5 years. Methods: Prospective cohort study. The subjects came from a finished multicenter, randomized and controlled clinical trial with a follow-up period of 1 year from April to November 2012. The clinical research centers were Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Peking University Third Hospital, Tianjin Medical University Eye Hospital, and Daping Hospital of Army Medical University. Cataract patients in the experimental group were implanted with A1-UV type IOL, while cataract patients in the control group were implanted with SN60WF type IOL, and monocular patients were enrolled. From April to May 2018, patients enrolled in the previous study were recalled for follow-up and continued observation. The visual acuity, spherical equivalent, postoperative complications, non-contact intraocular pressure and subjective evaluation results were statistically analyzed preoperatively, at 1 to 2 days, 1 week, 1 month, 3 months, 6 months, 1 year and 5 years after operation. The main statistical methods included Mann Whitney U test, Wilcoxon signed rank test, independent sample t test, chi square test and Fisher exact test. Results: A total of 42 subjects (22 in the experimental group and 20 in the control group) completed 5-year continuous observation. Among the 42 subjects, 28 were female and 14 were male. The age was (70±9) years, and the time from surgery to recall was (5.77±0.19) years. The age, gender distribution, left/right eye distribution, axial length, IOL power and nucleus hardness classification data of the experimental group and the control group were balanced and comparable (all P>0.05). At different visiting time points, there was no significant difference in the best corrected distance visual acuity (BCDVA), best corrected near visual acuity (BCNVA), uncorrected distance visual acuity (UCDVA) and uncorrected near visual acuity (UCNVA) between the groups (all P>0.05). At 5 years after operation, the UCDVA, BCDVA and BCNVA of the two groups were significantly improved compared with the baseline [all P<0.01; UCDVA was improved from 0.75 (0.30 to 1.30) to 0.10 (-0.10 to 0.70) in the experimental group and from 0.75 (0.30 to 1.60) to 0.20 (-0.10 to 0.80) in the control group; BCDVA was from 0.60 (0.10 to 1.00) to 0.00 (-0.10 to 0.54) in the experimental group and from 0.60 (0.10 to 1.60) to 0.10 (-0.10 to 0.50) in the control group; BCNVA was from 0.55 (0.00 to 1.10) to 0.10 (-0.10 to 0.60) in the experimental group and from 0.55 (0.10 to 1.60) to 0.10 (-0.20 to 0.60) in the control group], but there was no significant change in the UCNVA (both P>0.05). There were no significant differences in the spherical equivalent, intraocular pressure, subjective evaluation of visual adverse symptoms, distance vision spectacle independence and comprehensive evaluation of satisfaction between the groups (all P>0.05). In the experimental group, one eye (4.5%) had an abnormal pupil, one eye (4.5%) had an abnormal IOL with a few particles on the surface of the IOL but no glistening, and 3 eyes (13.6%) had posterior capsular opacification (PCO); in the control group, one eye (5.0%) had an abnormal cornea, five eyes (25.0%) had abnormal IOLs [one eye (5.0%) had IOL calcification, and four eyes (20.0%) had IOL glistening], and one eye (5.0%) had PCO with posterior capsular folds and IOL tilt. There was no significant difference in PCO and IOL abnormality between the two groups (both P>0.05), but there was significant difference in the occurrence of IOL glistening (P=0.04). Conclusion: The long-term effect of A1-UV aspheric IOL on improving the UCDVA is stable and good, with high subjective satisfaction of patients, a low incidence of PCO, no glistening and good biocompatibility, over the postoperative 5 years. (Chin J Ophthalmol, 2021, 57: 41-47).
目的： 评价白内障患者A1-UV型非球面人工晶状体（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2012年4至11月在首都医科大学附属北京同仁医院、北京大学第三医院、天津医科大学眼科医院、陆军军医大学大坪医院4家医院采用中央动态随机系统行白内障摘除A1-UV型IOL植入术（试验组）和SN60WF型IOL植入术（对照组）后随访1年的受试者（单眼入组）进行延续观察，记录术前及术后1~2 d、1周、1个月、3个月、6个月、1年、5年共8个访视时间点的视力、等效球镜度数、术后并发症、眼压和主观评价结果进行比较和分析。统计学方法主要包括Mann-Whitney U检验、Wilcoxon符号秩检验、独立样本t检验、χ²检验或Fisher确切概率检验。 结果： 42例受试者完成5年延续观察，其中女性28例，男性14例，年龄（70±9）岁，手术至召回时间为（5.77±0.19）年。试验组22例，对照组20例。两组年龄、性别分布、眼别分布、眼轴长度、IOL光焦度、核硬度分级资料均衡可比（均P>0.05）。在不同访视时间点，最佳矫正远视力、最佳矫正近视力、裸眼远视力、裸眼近视力两组间比较差异均无统计学意义（均P>0.05）。术后5年的裸眼远视力，试验组由术前0.75（0.30~1.30）改善为0.10（-0.10~0.70），对照组由术前0.75（0.30~1.60）改善为0.20（-0.10~0.80）；最佳矫正远视力，试验组由术前0.60（0.10~1.00）改善为0.00（-0.10~0.54），对照组由术前0.60（0.10~1.60）改善为0.10（-0.10~0.50）；最佳矫正近视力，试验组由术前0.55（0.00~1.10）改善为0.10（-0.10~0.60），对照组由术前0.55（0.10~1.60）改善为0.10（-0.20~0.60），术后5年与术前比较差异均有统计学意义（均P<0.01），两组裸眼近视力术后5年与术前比较均无明显变化（均P>0.05）。术后5年，等效球镜度数、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两组间差异均无统计学意义（均P>0.05）。术后5年，试验组22例患者中1例（4.5%）瞳孔异常，1例（4.5%）IOL异常（IOL表面出现少许颗粒），无IOL闪辉，3例（13.6%）后囊膜混浊（PCO）；对照组20例患者中1例（5.0%）角膜异常，5例（25.0%）IOL异常［1例（5.0%）IOL钙化、4例（20.0%）IOL闪辉］，1例（5.0%）PCO伴后囊膜褶皱及IOL倾斜。两组发生PCO和IOL异常比例差异无统计学意义（均P>0.05），发生IOL闪辉比例差异有统计学意义（P=0.04）。 结论： A1-UV型非球面IOL植入术后5年术眼的裸眼远视力良好且稳定，患者主观满意度高，有效性和安全性良好。（中华眼科杂志，2021，57：41-47）.
Keywords: Capsule opacification; Glistening; Lenses, intraocular; Treatment outcome; Visual acuity.