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

医学 视力 威尔科克森符号秩检验 随机化 人工晶状体 精确检验 统计显著性 眼压 曼惠特尼U检验 眼科 前瞻性队列研究 外科 随机对照试验 内科学
作者
Xudong Song,Yansheng Hao,Yongzhen Bao,Z H Li,H Zhang,Ailing Yu,Meng Zhao,Yusen Huang,JinHui Fang,Y Liu,Yanxiu Sun,N L Wang
出处
期刊:PubMed 卷期号:59 (2): 118-128
标识
DOI:10.3760/cma.j.cn112142-20220826-00417
摘要

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。.
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