Safety and efficacy of A1-UV aspheric intraocular lens implantation over the postoperative 5 years

Abstract

Objective: To evaluate the clinical safety and efficacy of A1-UV aspheric intraocular lens (IOL) implantation over the postoperative 5 years. Methods: Prospective cohort study. The subjects came from a finished multicenter, randomized and controlled clinical trial with a follow-up period of 1 year from April to November 2012. The clinical research centers were Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Peking University Third Hospital, Tianjin Medical University Eye Hospital, and Daping Hospital of Army Medical University. Cataract patients in the experimental group were implanted with A1-UV type IOL, while cataract patients in the control group were implanted with SN60WF type IOL, and monocular patients were enrolled. From April to May 2018, patients enrolled in the previous study were recalled for follow-up and continued observation. The visual acuity, spherical equivalent, postoperative complications, non-contact intraocular pressure and subjective evaluation results were statistically analyzed preoperatively, at 1 to 2 days, 1 week, 1 month, 3 months, 6 months, 1 year and 5 years after operation. The main statistical methods included Mann Whitney U test, Wilcoxon signed rank test, independent sample t test, chi square test and Fisher exact test. Results: A total of 42 subjects (22 in the experimental group and 20 in the control group) completed 5-year continuous observation. Among the 42 subjects, 28 were female and 14 were male. The age was (70±9) years, and the time from surgery to recall was (5.77±0.19) years. The age, gender distribution, left/right eye distribution, axial length, IOL power and nucleus hardness classification data of the experimental group and the control group were balanced and comparable (all P>0.05). At different visiting time points, there was no significant difference in the best corrected distance visual acuity (BCDVA), best corrected near visual acuity (BCNVA), uncorrected distance visual acuity (UCDVA) and uncorrected near visual acuity (UCNVA) between the groups (all P>0.05). At 5 years after operation, the UCDVA, BCDVA and BCNVA of the two groups were significantly improved compared with the baseline [all P<0.01; UCDVA was improved from 0.75 (0.30 to 1.30) to 0.10 (-0.10 to 0.70) in the experimental group and from 0.75 (0.30 to 1.60) to 0.20 (-0.10 to 0.80) in the control group; BCDVA was from 0.60 (0.10 to 1.00) to 0.00 (-0.10 to 0.54) in the experimental group and from 0.60 (0.10 to 1.60) to 0.10 (-0.10 to 0.50) in the control group; BCNVA was from 0.55 (0.00 to 1.10) to 0.10 (-0.10 to 0.60) in the experimental group and from 0.55 (0.10 to 1.60) to 0.10 (-0.20 to 0.60) in the control group], but there was no significant change in the UCNVA (both P>0.05). There were no significant differences in the spherical equivalent, intraocular pressure, subjective evaluation of visual adverse symptoms, distance vision spectacle independence and comprehensive evaluation of satisfaction between the groups (all P>0.05). In the experimental group, one eye (4.5%) had an abnormal pupil, one eye (4.5%) had an abnormal IOL with a few particles on the surface of the IOL but no glistening, and 3 eyes (13.6%) had posterior capsular opacification (PCO); in the control group, one eye (5.0%) had an abnormal cornea, five eyes (25.0%) had abnormal IOLs [one eye (5.0%) had IOL calcification, and four eyes (20.0%) had IOL glistening], and one eye (5.0%) had PCO with posterior capsular folds and IOL tilt. There was no significant difference in PCO and IOL abnormality between the two groups (both P>0.05), but there was significant difference in the occurrence of IOL glistening (P=0.04). Conclusion: The long-term effect of A1-UV aspheric IOL on improving the UCDVA is stable and good, with high subjective satisfaction of patients, a low incidence of PCO, no glistening and good biocompatibility, over the postoperative 5 years. (Chin J Ophthalmol, 2021, 57: 41-47).