Background To evaluate the 5-year results of Refractive Lenticule Extraction (ReLEx) as Small Incision Lenticule Extraction (SMILE) technique for treatment of myopia and myopic astigmatism.

Methods In 2008/2009, the worldwide first 91 eyes were treated using a novel surgical technique (SMILE), where a refractive lenticule of intrastromal corneal tissue is removed though a small incision completely eliminating flap-cutting. 56 out of 91 eyes of the original treatment group volunteered for re-examination 5 years after surgery. Uncorrected distance visual acuity and corrected distance visual acuity after 5 years, objective and manifest refractions as well as evaluation of the interface and corneal surface by slit-lamp examination were documented. Late side effects like corneal scars, corneal ectasia, persistent dry eye symptoms or cataract were documented.

Results 5 years postoperatively, no significant change to the 6-month data was found. Spherical equivalent was −0.375 D and therefore close to target refraction (emmetropia). 32 of the 56 eyes had gained 1–2 Snellen lines. There was no loss of 2 or more lines over the 5-year period. Regression in the long term was 0.48 D.

Conclusions This first long-term study demonstrates SMILE to be an effective, stable and safe procedure for treatment of myopia and myopic astigmatism.

Clinical trial number DE/CA93/KP/07/001. Post-results.