5-Year Results of Small Incision Lenticule Extraction
British Journal of Ophthalmology
In 2008/2009, the first group of patients underwent a new procedure, refractive lenticule extraction (ReLEx), with the small incision lenticule extraction (SMILE) technique for treatment of myopia and myopic astigmatism. Blum et al. performed a 5-year follow-up study among these original patients and found that the procedure was effective, stable, and safe in the long term.
In this study, 56 eyes (30 patients) out of 91 eyes in the original treatment group volunteered to be reexamined 5 years after surgery. Average age at follow-up was 42 years (range, 26-61). Uncorrected and corrected distance visual acuity and objective and manifest refractions were measured, and the interface and corneal surface were examined at the slit lamp. Late side effects such as corneal scars, corneal ectasia, persistent dry eye symptoms, or cataract were documented.
The researchers found no significant changes in the data recorded 6 months postoperatively and the 5-year results. Spherical equivalent was −0.375 D (which represents 0.48 D long-term regression), remaining close to target refraction (emmetropia). There was a trend toward improvement between 6 months and 5 years, but it was not statistically significant. No eyes lost 2 or more lines over the 5-year period.
In terms of safety, all patients were routinely treated for dry eye symptoms in the first 3 months after SMILE, but none needed further treatment after 3 months. No patients reported any associated side effects at the 5-year follow-up. Furthermore, no signs of corneal ectasia, cataract formation, or other ocular pathology were found in any of the eyes.
In conclusion, the researchers stated that this first long-term study of SMILE demonstrates that it is an effective, stable, and safe procedure for treatment of myopia and myopic astigmatism.
The original article can be found here.