Comparative study of small-incision lenticule extraction and phakic intraocular lens implantation for the correction of high myopia: 6-year results.

Purpose: To compare the long-term safety, efficacy, and complications of small-incision lenticule extraction (SMILE) and flexible iris-fixated anterior chamber phakic intraocular lens (pIOL) implantation for the treatment of high myopia. Setting: University of Health Science Turkey, Beyoglu Eye Training and Research Hospital, Istanbul, Turkey. Design: Retrospective comparative case series. Methods: Data of patients who underwent SMILE or pIOL (Artiflex) implantation for myopia were retrospectively reviewed. Only patients with preoperative manifest refraction spherical equivalent from -6.00 to -10.00 diopters (D) were included in the study. Results: There were 47 eyes of 32 patients in the SMILE group and 52 eyes of 29 patients in the pIOL group. The mean postoperative follow-up was 63.75 +/- 18.40 months in the SMILE group and 65.38 +/- 16.22 months in the p-IOL group (P =.71). At 6 years postoperatively, refractive predictability was slightly better in the pIOL group, and the percentages of eyes within +/-0.50 D of the attempted correction were 77% and 83% in the SMILE and pIOL groups, respectively. Although mean uncorrected distance visual acuity was comparable (SMILE, 0.12 +/- 0.06 logarithm of the minimum angle of resolution [logMAR]; p-IOL, 0.09 +/- 0.05 logMAR), the safety indices (1.08 +/- 0.22 vs 1.11 +/- 0.20; P =.02) and the efficacy indices (0.92 +/- 0.24 vs 1.11 +/- 0.22; P =.03) were statistically significantly higher after pIOL implantation. Despite a mean of 11.09% of the endothelial cell being lost at 6 years after pIOL implantation, no pIOL was explanted due to endothelial cell loss. Conclusions: In this comparative and long-term study, iris-fixated anterior chamber pIOL implantation for high myopic correction showed slightly better safety and efficacy profiles but with statistically significant endothelial cell loss. [ABSTRACT FROM AUTHOR]