SMILE Versus Implantable Collamer Lens Implantation for High Myopia: A Matched Comparative Study

Abstract

Purpose: To compare the safety, efficacy, and patient-reported quality of vision of small incision lenticule extraction (SMILE) and implantable Collamer lens (ICL) implantation for the treatment of high myopia.

Methods: A database of 1,634 SMILE (Carl Zeiss Meditec AG, Jena, Germany) and 225 ICL implantation (STAAR Surgical, Monrovia, CA) procedures was screened for patients with a binocular preoperative manifest refraction spherical equivalent between -6.00 and -10.00 diopters (D) and plano target refraction. One-to-one matching was performed by preoperative manifest refraction spherical equivalent, age, and pupil size. All identified patients were then prospectively examined at their next regular postoperative follow-up visit and presented with the standardized and clinically validated Quality of Vision questionnaire to gauge patient-reported postoperative visual quality.

Results: A total of 80 eyes (40 patients) were eligible for 1:1 matching. Mean postoperative follow-up was 27.8 ± 14.3 months in the SMILE group and 26.6 ± 17.7 months in the ICL group (P = .44). Regarding the percentage of eyes within ±0.50 D of plano target, refractive predictability was better in eyes treated with ICL implantation (90%) than SMILE (72.5%) (P = .045). Mean UDVA was comparable (ICL: -0.09 ± 0.10 logMAR; SMILE: -0.06 ± 0.09 logMAR; P < .09), but the efficacy (1.28 vs 1.05; P < .001) and safety (1.31 ± 0.22 vs 1.10 ± 0.25; P < .001) indices were higher after ICL implantation. ICL implantation induced significantly fewer higher order aberrations (total higher order aberrations: SMILE 0.724 ± 0.174 µm vs ICL 0.436 ± 0.114 µm; P < .01). Regarding subjective quality of vision, patients who had ICL implantation were significantly less bothered by visual disturbances, which were mainly halos after ICL and starbursts and fluctuations of vision after SMILE (P < .05).

Conclusions: In this refraction-matched comparative study, ICL implantation for high myopia yielded better refractive accuracy, better uncorrected distance visual acuity, fewer higher order aberrations, and better subjective quality of vision than SMILE. [J Refract Surg. 2020;36(3):150-159.].