Femtosecond laser based small incision lenticule extraction for moderate and high myopia. Jesper Hjortdal, Sven Asp, Anders Ivarsen, Anders Vestergaard Department of Ophthalmology, Aarhus University Hospital, Denmark Purpose: ReLEx® smile is a new keratorefractive procedure whereby a stromal lenticule is cut by a femtosecond laser and manually extracted through a peripheral corneal tunnel. The purpose of the prospective quality study is to present our initial clinical experience with ReLEx smile for treatment of moderate and high myopia. Methods: 379 eyes (198 patients) were treated for myopia (spherical equivalent (SE) ranging from -13.13 to -1.63 D, mean -7.28 D) with ReLEx smile and followed for 3 months. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), spherical equivalent (SE), proportion of eyes within ± 0.5/1.0 D, loss/gain of lines of CDVA, patient satisfaction, and complications were registered. Results: In total, 332 eyes completed the 3-month follow up. For eyes with emmetropia as target refraction, 83% had an UDVA of ≥20/25 (logMAR ≤0.1) at day 1 after surgery, increasing to 91% at 3 months. Nine eyes lost ≥ 2 lines of CDVA, and 42 eyes lost 1 line of CDVA. Loss of CDVA was mainly caused by interface scatter, and occurred mostly during the initial period of the study. Two eyes gained 2 lines, and 53 eyes gained 1 line of CDVA at the 3-month follow-up. Comparing attempted vs. achieved correction, the proportion of eyes within ± 0.50 D was 77.1 %, and 94.3% were within ± 1.0 D. The difference in attempted vs. achieved SE correction was -0.13 ± 0.49 D (range 1.50 to -1.88 D). Ninety-five percent of the patients would recommend refractive surgery to others. Conclusions: ReLEx smile is a flapless all-in-one femtosecond laser refractive procedure. Refractive predictability, safety and patient satisfaction at 3 months seems equal to ReLEx flex and FS-LASIK. Optimizing laser energy settings and surgeon experience is important to minimize initial inferior results.