KEYWORDSSmall incision lenticule extraction (SMILE), high myopia, long-term follow-up 2 Abstract Background To investigate long-term refractive visual quality outcomes and vision-related quality of life after small-incision lenticule extraction (SMILE) in the treatment of high myopia.Methods Thirty patients (60 eyes) with high myopia who underwent SMILE more than 5 years previously were selected as the SMILE group. Another 30 high myopia patients (60 eyes) who had worn corrective spectacles for more than 5 years were selected as the control group. In the SMILE group, the postoperative follow-up times were 3 months, 6 months, 1 year and 5 years. The uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), spherical equivalent (SE), and ocular axial length (AL) were analysed. The Chinese version of the National Eye Institute Visual Function Questionnaire-25 (CHI-NEI-VFQ-25) was used to evaluate the vision-related quality of life in the SMILE group and the control group. ResultsIn the SMILE group, the mean preoperative SE was -7.29±0.87 D (range -6.00 to -9.125 D).The efficacy index and safety index of SMILE were 1.09±0.18 and 1.19±0.12, respectively. Five years postoperatively, 44 eyes (73%) obtained a visual acuity of 20/20 or better. There were no eyes with CDVA loss of one or more Snellen lines. Forty-nine eyes (82%) and 57 eyes (95%) were within ±0.50 D and ±1.00 D of attempted correction, respectively. Forty-eight eyes (80%) had astigmatism < 0.50 D. The postoperative mean SE values at 3 months, 6 months, 1 year, and 5 years were 0.11±0.44 D, 0.07±0.45 D, -0.02±0.41 D, and -0.15±0.46 D, respectively. No significant change was observed in the ocular axial length from before operation to 5 years postoperatively (26.08±0.96 mm vs 26.01±0.94 mm, p>0.05). Compared to the control group, the SMILE group showed a significantly higher total score on the CHI-NEI-VFQ-25 (90.14 vs 81.43, p < 0.001). ConclusionsIn the present study, in a long-term follow-up, we demonstrated that correcting high myopia with SMILE is safe, effective, and predictable. In addition, there is slight undercorrection. BackgroundRecently, femtosecond lasers have been widely used in ophthalmology, such as in anterior capsulotomy with femtosecond lasers in cataract surgery, femtosecond laser-assisted keratoplasty, flap construction with femtosecond lasers in FS-LASIK and lens creation in the corneal stroma with