[Three Years Follow-up Study after Refractive Small Incision Lenticule Extraction (SMILE) Using 500 kHz Femtosecond Laser in "Fast Mode"]

Abstract

Background The aim of this clinical trial was to check the results of laser built-in settings 3 years after ReLEx SMILE for moderate and high myopia in unselected "real life" patients. Patients and Methods 50 myopic eyes of 27 patients were called in for examination after 3 years. 25 of these eyes with a preoperative myopia under - 6D comprised the "moderate myopia subgroup". All surgeries were performed with the 500 kHz VisuMax® femtosecond laser (Carl Zeiss Meditec AG, Jena) in the "fast mode" setting. Results The spherical equivalent (SE) of the entire group changed from - 6.18 D (± 1.91) prior to surgery to - 0.18 D (± 0.39) 3 years later. The preoperative SE in the moderate myopia subgroup changed from - 4.71 D (± 0.94) to - 0.04 D (± 0.23). 14 % of 50 eyes gained one line and 22 % lost one line of CDVA. The regression between month 3 and 36 was 0.07D for the entire group and 0.06 D for the moderate myopia subgroup. There were no late side effects. Primary undercorrection was predominantly seen in eyes over - 6 D. Conclusion ReLEx SMILE shows remarkable stability over the entire range of myopias after 3 years, however primary undercorrection occurs predominantly in eyes of - 6.0 D, which necessitates nomogram adjustment.