gms | German Medical Science

Purpose: To evaluate the 10-year results of Refractive Lenticule Extraction (ReLEx®) as Small Incision Lenticule Extraction technique (SMILE) for treatment of myopia and myopic astigmatism.

Setting: Department of Ophthalmology, Helios Hospital Erfurt, Germany and Department of Ophthalmology, Phillips University of Marburg, Germany.

Design: Long-term follow-up of a prospective clinical trial.

Methods: In 2008/09, 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 10 years after surgery. Main outcome measures: Uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) after 10 years, objective and manifest refraction as well as evaluation of the interface and corneal surface by slit-lamp examination. Late side effects like corneal scars, corneal ectasia, persistent dry eye symptoms or cataract were documented.

Results: 10 years postoperatively, no significant change to the 6-month data was found. Spherical equivalent (SEQ) was -0.35 (+/-0.66) D and therefore close to target refraction. 16 of the 56 eyes (29%) had gained 1 to 2 Snellen lines. There was no loss of 2 or more lines in the long term. Regression over the decade was minimal.

Conclusions: This 10 years long-term study demonstrates SMILE to be an effective, stable and safe procedure for treatment of myopia and myopic astigmatism.