Five-year results of refractive lenticule extraction.

PURPOSE To evaluate the 5-year results of femtosecond laser-assisted refractive lenticule extraction (ReLEx-FLEx) for the treatment of myopia and myopic astigmatism. SETTING Departments of Ophthalmology, Helios Klinikum Erfurt, Erfurt, and Phillips Universität Marburg, Marburg, Germany. DESIGN Prospective clinical trial. METHODS This was a follow-up of a prospective study that evaluated the first patients treated with refractive lenticule extraction, in which a flap and a refractive lenticule of intrastromal corneal tissue were simultaneously cut using a 200 kHz Visumax femtosecond laser system. Thereafter, the lenticule was manually removed and the flap repositioned. The main outcome measures were the uncorrected and corrected distance visual acuities, objective and manifest refractions, slitlamp examination findings, and side effects after 5 years. RESULTS Forty-one of 108 eyes in the original treatment group were available for a reexamination. Five years postoperatively, 100% of eyes were within ±1.00 diopter (D) of the intended correction and 73% were within ±0.50 D. By 5 years, no eye had lost 2 or more Snellen lines and 1 eye had lost 1 Snellen line. The mean regression was 0.07 D. CONCLUSION Long-term data indicate that refractive lenticule extraction is an effective and safe procedure for the treatment of myopia and myopic astigmatism and has excellent stability. FINANCIAL DISCLOSURE No author has a financial or proprietary interest in any material or method mentioned.