A 10-year study has concluded small incision lenticule extraction (SMILE) is a safe and effective procedure for the treatment of myopia and myopic astigmatism.
In Germany in 2008–2009, 91 eyes were treated using the novel surgical technique (SMILE), in which a refractive lenticule of intrastromal corneal tissue is removed through a small incision, completely eliminating flap cutting. A total of 56 of the original treatment group volunteered for re-examination 10 years after surgery, with uncorrected and corrected distance visual acuity, objective and manifest refraction, evaluation of the interface and corneal surface by slit-lamp examination being tested. There were found to be no significant changes from the results taken six months post-operatively.
Spherical equivalent was −0.35 ± 0.66 diopters and therefore close to target refraction. Sixteen of the 56 eyes (29%) had gained one to two Snellen lines. There was no loss of two or more lines in the long term. Regression was −0.35 ± 0.66 diopters over the 10-year period.
Late side effects such as corneal scarring, corneal ectasia, persistent dry eye symptoms, or cataract were documented in the study published in the Journal of Refractive Surgery.