[Visual outcomes 5 years after small incision lenticule extraction (SMILE), surgery on spherocylindrical myopia eyes, from 616 eyes].

OBJECTIVE: Determine if the visual criteria of the technique of surgery refractive by Femtosecond Laser-assisted duckweed Extraction - Small Lenticule Extraction (FLEx-Smile® ), realized in the laser femtosecond VisuMax® (Carl Zeiss Meditec, Jena, Germany), are stable, secure, effective and predictable in the long term, to the nearsighted and astigmatic.

MODEL OF THE STUDY: Retrospective study, monocentric with data collected between March 2012 and March 2017.

PARTICIPANTS: The study included 616 eyes of 309 nearsighted and astigmatic patients (spherical equivalent from 1 to 11 D). They were followed in postoperative immediate (D+1), in 3 months, in 1 year and in 5 years. The taken measures include the refraction, the uncorrected visual acuteness (UVAC) and the best visual corrected acuteness (BVAC).

THE PRIMARY AND SECONDARY ASSESSMENT CRITERIA: The criteria of evaluation were based on the BVAC, the refractive stability, the index of security (IS: MAVC to preoperative D+1/BVAC before operation) and the predictability (percentage of eyes in±1 D of SE target).

RESULTS: UVAC was better 5th year than after the intervention (P=0.001) and 88% of the operated eyes had an UVAC in 8/10 (logMAR=0.1). For the stability refractive, the patients became nearsighted between the intervention and 5th year (P=0.001), with a regression of 0.240 D. The indication of safety was better 5th year than the day after the intervention (P=0.001), 92% of eyes operated in 5 years were 0.5 D of SE target and 77% of eyes had lost no line.

CONCLUSION: SMILE is a good technique of surgery refractive stable, secure, effective and predictable on the long term.