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目的::对比分析NGENUITYn ? 3D导航与常规显微镜下有晶状体眼人工晶状体(ICL)植入术的临床效果。n 方法::前瞻性随机对照研究。选取2020年10—11月在西安爱尔眼科医院屈光与老视晶状体中心行ICL或散光型ICL(TICL)植入术的近视患者60例(60眼)。采用随机数字表法分为NGENUITYn ? 3D导航组(3D组)30例和常规显微镜组(常规组)30例。对最小光照明度、ICL植入时间、TICL调位时间、手术总时间等术中操作参数以及手术前后眼压变化、术后随访6个月的视力变化、等效球镜度(SE)变化、TICL离轴偏差度、结膜下出血率等临床参数进行比较。采用n t检验和n χ2检验进行数据分析。n 结果::2组术前年龄、SE及TICL占比差异均无统计学意义。常规组和3D组最小光照明度分别为(10 800±1 300)lx和(5 000±1 500)lx,ICL植入时间分别为(12.6±3.7)s和(8.7±2.4)s,TICL调位时间分别为(32.4±5.4)s和(16.3±2.4)s,手术总时间分别为(415.4±43.3)s和(331.0±33.7)s,2组间这些术中操作参数差异均有统计学意义(n t=7.31,n P=0.003;n t=6.32,n P=0.001;n t=8.34,n P=0.001;n t=5.83,n P=0.002)。常规组、3D组术后3 h眼压值均较术前升高,术后3 h与术前眼压差值分别为(5.24±3.42)mmHg和(3.12±2.15)mmHg(1 mmHg=0.133 kPa),组间差异有统计学意义(n t=2.82,n P=0.002)。术后6个月,常规组、3D组离轴旋转度轴位偏差分别为(5.68±0.18)°和(3.23±0.13)°,组间差异有统计学意义(n t=3.22,n P=0.002)。组间术后结膜下出血率、裸眼视力、最佳矫正视力等差异均无统计学意义。n 结论::与常规显微镜下ICL手术相比,NGENUITYn ? 3D导航引导下ICL术中可降低光照亮度、缩短手术时间,术后散光晶状体平均离轴旋转度轴位偏差更小。n “,”Objective::To evaluate the operation and clinical applications of the NGENUITYn ? 3D-guided system and the binocular microscope visualization system for posterior chamber implantable collamer lens implantation (ICL).n Methods::This was a randomized controlled study. A total of 60 patients (60 eyes) who underwent ICL or Toric ICL (TICL) surgery in the Xi’an Aier Eye Hospital from October to November 2020 were enrolled and randomly divided into two groups that included 30 patients (30 eyes) in the 3D group and 30 patients (30 eyes) in the microscope group. The following observation indexes were obtained during this study: the operation indicators included the minimum light illuminance, ICL implant time, TICL posit time and total operation time and the clinical outcome indicators that included changes in the patients’ intraocular pressure, visual acuity, manifest refraction spherical equivalent (MRSE), the average off-axis rotation axial deviation and the rate of subconjunctival hemorrhage. The n t test and Chi square test were used for statistical analysis.n Results::There were no significant differences between two groups in age, MRSE or TICL proportion at baseline. There was a statistically significant difference between the microscope group and the 3D group in the minimum light illuminance (10 800±1 300 lux, 5 000±1 500 lux), the ICL implant time (12.6±3.7 s, 8.7±2.4 s), the TICL posit time (32.4±5.4 s, 16.3±2.4 s), and the total operation time (415.4±43.3 s, 331.0±33.7 s). All differences were statistically significant (n t=7.31, n P=0.003; n t=6.32, n P=0.001;n t=8.34, n P=0.001; n t=5.83, n P=0.002). The differences in intraocular pressure changes 3 hours after surgery (5.24±3.42 mmHg, 3.12±2.15 mmHg) and the average off-axis rotation axial deviation (5.68±0.18°, 3.23±0.13°). Comparisons were both statistically significant (n t=2.82, n P=0.002; n t=3.22, n P=0.002). There were no significant differences between groups after the operation in the rate of subconjunctival hemorrhage, uncorrected visual acuity, best corrected visual acuity or residual refractive error.n Conclusions::Compared with the binocular microscopy system ICL, the intraoperative light illuminance, operative time and the average off-axis rotation axial deviation can be reduced more by the NGENUITYn ? 3D-guided system ICL.n