Abstract
Objective: Through the combined analysis of data from two clinical trials, the clinical safety and efficacy of aspheric intraocular lens A1-UV implantation in cataract patients was evaluated at 1 year after surgery. Methods: A total of 239 subjects (239 eyes) were enrolled, including 117 subjects in the A1-UV group (study group), 61 subjects in the SN60WF group (control group 1) and AQBHL group (control group 2), respectively. Follow-up time points included: preoperative, intraoperative and postoperative 1~2days, 1 week, 1 month, 3 months, 6 months and 1 year. The evaluation indexes included: visual acuity, refraction, contrast sensitivity, intraocular pressure and complications. Statistical methods mainly include Wilcoxon rank-sum test, independent samples t-test, chi-square test or Fisher exact probability test. Results: The uncorrected distance visual acuity of the A1-UV group increased from logMAR 0.77±0.33 preoperatively to 0.15±0.22 at 1 year after surgery, from 0.74±0.33 in the SN60WF group to 0.18±0.23 at 1 year after surgery, and from 0.78±0.34 in the AQBHL group to 0.21±0.24 at 1 year after surgery. For best-corrected distance visual acuity, the A1-UV group increased from logMAR 0.60±0.36 preoperatively to 0.05±0.10 at 1 year after surgery, the SN60WF group increased from 0.59±0.36 preoperatively to 0.07±0.15 at 1 year after surgery, and the AQBHL group increased from 0.59±0.35 preoperatively to 0.08±0.11 at 1 year after operation. There was no significant difference between the A1-UV group and the other two groups (all P>0.05). At different follow-up times after surgery, the residual diopters was significantly lower than that before operation (all P<0.05), and the refractive error before operation was effectively corrected. The contrast sensitivity was high, and the visual function was better. The mean intraocular pressure of the subjects implanted with A1-UV was within the normal range during each follow-up period after surgery. None of the patients had serious adverse events related to intraocular lens. Conclusion: The efficacy and safety of A1-UV foldable one-piece intraocular lens in cataract treatment are good
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