Background: To report one year results of the first cohort of routine refractive lenticule extraction through a small incision (ReLEx SMILE) for correction of myopia and myopic astigmatism.
Methods: Fifty-four eyes of 27 patients with spherical equivalent of -4.68 ± 1.29D who underwent routine ReLEx SMILE by a single surgeon were prospectively followed-up for 1 year. We used the VisuMax femtosecond laser system (Carl Zeiss Meditec AG, Germany) with a 500 kHz repetition rate. Folow-up intervals were at 1 day, 1 week, 1, 3, 6, and 12 months after surgery. We obtained following parameters: uncorrected (UDVA) and distance-corrected visual acuity (CDVA), contrast sensitivity, and wave front measurements. We also recorded all complications.
Results: Because of suction loss in one eye, 12-month results were obtained in 53 eyes as follows. After 1 year, 88% of eyes with plano target had an UDVA of 20/20 or better. Twelve percent of eyes lost 1 line of CDVA, while 31% gained 1 line and 3% gained 2 lines. The mean SE after 1 year was -0.19 ± 0.19. The mean refraction change between month 1 and 12 was 0.08 D. Neither mesopic nor photopic contrast sensitivity showed any significant changes. The high-order aberrations (HOA) increased from 0.17 to 0.27 μm (Malacara notation). No visually threatening complications were observed.
Conclusion: In this first cohort, ReLEx SMILE produced satisfactory refractive outcomes with moderate induction of HOA and unaffected contrast sensitivity after 1 year.