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, Beyoğlu Eye Training and Research Hospital, İstanbul, 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.