Abstract:AIM: To compare and calculate the 3-year refractive results, higher-order aberrations (HOAs), contrast sensitivity (CS) and dry eye parameters after small incision lenticule extraction (SMILE) and wavefront-guided femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) for correction of high myopia and myopic astigmatism. METHODS: In this prospective, non-randomized comparative study, 78 eyes with spherical equivalent (SE) of -8.11±1.09 diopters (D) received a SMILE surgery, and 65 eyes with SE of -8.05±1.12 D received a wavefront-guided FS-LASIK surgery with the VisuMax femtosecond laser (Carl Zeiss Meditec, Jena, Germany) for flap cutting. Visual acuity, manifest refraction, CS, HOAs, ocular surface disease index (OSDI) and tear break-up time (TBUT) were evaluated during a 3-year follow-up. RESULTS: The difference of uncorrected distance visual acuity (UDVA) postoperatively was achieved at 1mo and at 3mo, whereas the difference of the mean UDVA between two groups at 3y were not statistically significant (t=-1.59, P=0.13). The postoperative change of SE was 0.89 D in the FS-LASIK group (t=5.76, P=0.00), and 0.14 D in the SMILE group (t=0.54, P=0.59) from 1mo to 3y after surgery. At 3-year postoperatively, both HOAs and spherical aberrations in the SMILE group were obviously less than those in the FS-LASIK group (P=0.00), but the coma root mean square (RMS) was higher in the SMILE group (0.59±0.26) than in the FS-LASIK group (0.29±0.14, P=0.00). The mesopic CS values between two groups were not statistically significant at 3y postoperatively. Compared with the FS-LASIK group, lower OSDI scores and longer TBUT values were found in the SMILE group at 1mo and 3mo postoperatively. With regard to safety, no eye lost any line of CDVA in both groups at 3y after surgery. CONCLUSION: Both SMILE and wavefront-guided FS-LASIK procedures provide good visual outcomes. Both procedures are effective and safe, but SMILE surgery achieve more stable long-term refractive outcome and better control of early postoperative dry eye as compared to FS-LASIK.