A multicenter study of the effectiveness and safety of Toric intraocular lens implantation

Objective To evaluate the effectiveness and safety of Proming®Toric intraocular lens (IOL) in adults with cataract combined with corneal regular astigmatism. Methods Multicentre, randomized, open and positive parallel controlled clinical study. A total of 121 patients (121 eyes) who had cataract combined with corneal regular astigmatism and met the inclusion criteria were enrolled in 9 hospitals from May 2014 to May 2016. There were 45 males and 76 females and the median age was 71 (42-88) years old. A total of 121 patients (121 eyes) were randomly assigned to the study group and the control group through the Central Randomization System. Sixty patients (60 eyes) of the study group were implanted with Proming®Toric IOL (Model: AT1BH-AT6BH) from Eyebright Medical Technology (Beijing) Co., Ltd., and 61 patients (61 eyes) of the control group were implanted with AcrySof ®IQ Toric IOL (Model: SN6AT2-SN6AT7) from Alcon Laboratories, Inc. The visual acuity, IOL axial position, slit lamp examination, residual astigmatism and contrast sensitivity were recorded at 1 day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively. Statistical analysis was performed using χ2 test, independent sample t test, Mann-Whitney U test, Friedman repeated measured ANOVA on ranks and non-parametric 2-factor variance analysis. Results A total of 118 patients completed 6 months of follow-up, including 59 from the study group and 59 from the control group. The difference between the two groups in terms of the percentage of best corrected distance visual acuity (BCDVA) reaching 20/40 was 1.69% [100% (59/59) vs. 98.31% (58/59) ], and the lower limit of the 95% CI (-1.60%) was greater than -10.00%. A total of 90 patients were followed up for 1 year, including 43 patients from study group and 47 patients from control group. At 1 year after operation, the percentages of the BCDVA up to 20/40 were 97.67%(42/43) in the study group and 97.87% (46/47) in the control group, and there was no significant difference between the two groups (χ2=0.00, P=0.95);the percentages of the uncorrected distance visual acuity (UCDVA) up to 20/40 were 81.40%(35/43) in the study group and 82.98%(39/47) in the control group, and there was no significant difference between the two groups (χ2=0.04, P=0.84). At 1 year follow-up, the difference of contrast sensitivity at 18.0 c/d under the bright light, dark light, bright glare and dark glare between the two groups was not statistically significant (U=468.50, P=0.17;U=528.00, P=0.28;U=465.50, P=0.19;U=629.00, P=0.39);the difference of residual astigmatism between the two groups was not statistically significant (U=798.50, P=0.08);the difference of IOL rotation degree between the two groups was not statistically significant (U=869.00, P=0.25). There were no severe inflammatory responses nor other complications associated with IOL in both groups at each follow-up point. Conclusion The visual quality, astigmatism correction effect, rotation stability and safety of Proming®Toric IOL for the treatment of cataract combined with corneal regular astigmatism is equivalent to AcrySof® IQ Toric IOL. (Chin J Ophthalmol, 2018, 54: 349-356) Key words: Lenses, intraocular; Contrast sensitivity; Visual acuity; Astigmatism