To present initial clinical experience with small-incision lenticule extraction for the treatment of moderate to high myopia. Department of Ophthalmology, Aarhus University Hospital, Aarhus, Denmark. Prospective clinical study. For small-incision lenticule extraction, an intrastromal lenticule was cut with a femtosecond laser and manually extracted without creation of a flap. Patients were treated and followed for 3 months. Only 1 randomly chosen eye of each patient was used in the statistical analyses. The study enrolled 144 patients. The mean preoperative spherical equivalent was -7.18 diopters (D) ± 1.57 (SD). Of eyes with emmetropia as target refraction, 40% had an uncorrected distance visual acuity of 0.1 logMAR or less 1 day after surgery; this increased to 73% at 3 months. The mean corrected distance visual acuity (CDVA) improved significantly from -0.01 (logMAR) preoperatively to -0.03 3 months postoperatively. None of the 127 eyes lost 2 lines or more of CDVA and 6 eyes lost 1 line of CDVA after 3 months. In contrast, 1 eye gained 2 lines and 24 eyes gained 1 line of CDVA. The achieved refraction was a mean of -0.09 ± 0.45 D from the attempted refraction. Of the eyes, 77% were within ±0.50 D and 95% were within ±1.00 D. Ninety-five percent of the patients would recommend the procedure to others. The refractive predictability, safety, and patient satisfaction 3 months after small-incision lenticule extraction were high and comparable to results in previous studies of femtosecond laser-assisted techniques. Drs. Hjortdal and Asp received travel reimbursement from Carl Zeiss Meditec AG, Jena, Germany. No other author has a financial or proprietary interest in any material or method mentioned. Copyright © 2012 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.