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

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 differences in intraocular pressure, subjective evaluation of visual adverse symptoms, distance vision spectacle independence, or overall satisfaction evaluation between the two groups (all P>0.05). The IOL rotation was 3.0°(1.0°, 6.0°) in the study group and 4.0°(2.0°, 6.0°)in the control group (U=185.50,P=0.574), indicating no significant difference between the groups in terms of rotational stability. Five years after surgery, there were 7 cases of posterior capsular opacification in the study group and 4 cases in the control group. There were no cases of IOL glistening in the study group, but 5 cases (26.32%) were observed in the control group. Conclusions: The long-term effects of Proming® toric IOL implantation in correcting cataracts with regular corneal astigmatism are clear after five years, with few complications and stable results.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-Whitney U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期疗效确切、并发症少且效果稳定。.