5 Jahresergebnisse der ersten Machbarkeitsstudie des Small-Incision-Lenticule-Extraction-Verfahrens (SMILE)

This work shows the results of a first small incision lenticule extraction feasibility study at least five years after surgery. A refractive procedure, which has been established worldwide. Developed from the FLEX process, where the cutting of a flap was still necessary, the flapless SMILE method was developed. For SMILE and FLEX, refractive correction is performed exclusively by a femtosecond laser. In the years 2007-2009, 91 eyes were operated under the SMILE procedure in a study. The content of this work is the voluntary follow-up to the collection of long-term objective data on safety, predictability, stability and efficiency. In addition, late complications should be established and the subjective satisfaction should be sought. 56 eyes out of 30 test persons, whom were treated by SMILE procedure, were recruited. Reflecting to the previous follow up refraction and visual acuity, pachymetry, wave front analysis, corneal topography, examination of the anterior part of the eye were made. The subjective satisfaction was determined with a standardized survey. The statistical analysis has been done with the Wilcoxon-tests and t-tests. After 5 years, 50 % of the eyes were within +0.5 D and 80 % within +1.0 D of the target refraction. At least the initial visual acuity reached 88 % of the eyes, 13 % of the eyes lost one line. No late complications were detected. 93 % of the test persons were sat- isfied with the refractive results and 95 % would undergo surgery again. Five years after surgery a low intraocular pressure in association with a reduced corneal thickness was detected. This connection was already seen one year after surgery but no significant difference was detected. Alltogether, five years postoperatively SMILE appears to produce good and stable refractive results, The treatment of myopia (up to -10 D) and astigmatism (up to -5 D) is possible. Meanwhile, first results for the treatment of hyperopia are also available (Blum 2013; Se- kundo 2016). The SMILE-procedure found its place in today’s refractive corneal surgery for the treatment of myopia and astigmatism. In the future, through further development of the procedure even better results are to be expected in follow-up studies. 65 The results of this study were published in the British Journal of Ophthalmology in 2016 (Blum 2016).