Background: This clinical trial is focused on the 12-month results of a new method for refractive correction in myopia, called "small incision lenticule extraction" (SMILE).
Patients and methods: In a prospective study 91 eyes were treated with the new refractive procedure and the results were published after 6 months. A lenticule of intrastromal corneal tissue is cut utilising the Carl Zeiss Meditec AG (Jena, Germany) VisuMax femtosecond laser system. Thereafter, this lenticule is manually removed without lifting a flap. 55 eyes of 33 patients volunteered for a 12-month follow-up. UCVA and BSCVA after 12 months, objective and manifest refraction as well as slit-lamp examination and late side effects were documented.
Results: 55 eyes of 33 patients were re-examined in this study 12 months after surgery. The spherical equivalent before surgery was - 4.66 (± 1.75) D; after 12 months - 0.11 (± 0.42) D was manifest. No significant change was observed compared to the 6-month control. Starting with UCVA of 0.1 (± 0.06) before surgery. UCVA was 1.02 (± 0.3) after 12 months. One eye lost more than two lines. All other patients did not have any late side effects.
Conclusion: The one-year results of this new procedure are encouraging. Especially stability of the correction of myopia and myopic astigmatism with the SMILE procedure is very good.
Georg Thieme Verlag KG Stuttgart · New York.