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

To evaluate the clinical safety and efficacy of toric intraocular lens (IOL) implantation for more than 5 years. 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 test, independent sample -test, Wilcoxon signed rank test, paired sample -test, chi-square test, and Fisher's exact test. 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 . 0.16±0.13, 0.17,0.752), best corrected distance visual acuity[0.00(0.00, 0.20) 0.05±0.10, 188.00, 0.880], uncorrected near visual acuity[0.50 (0.20, 0.60) 0.42±0.20, 0.35, =0.857], and best corrected near visual acuity (0.13±0.16 0.17±0.23, 161.00, =0.884) between the two groups. However, all measures improved significantly from baseline levels in both groups (all 0.05). Five years after surgery, no matter objective refraction [(-0.67±0.85) D (-0.73±1.08)D] or subjective refraction[-0.50 (-1.00, 0.00)D (0.69±0.87)D], the degree of cylindrical degree is significantly lower than preoperative corneal astigmatism [(1.27±0.49) D (1.34±0.82) D, all 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 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 (=185.50,0.574), 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. 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.