First efficacy and safety study of femtosecond lenticule extraction for the correction of myopia: six-month results.

Purpose: To prospectively study the feasibility of femtosecond lenticule extraction (FLE), a new method of refractive correction.

Setting: Department of Ophthalmology, Philipps University of Marburg and Helios Clinic, Erfurt, Germany.

Methods: A flap and a lenticule of intrastromal corneal tissue were simultaneously cut with a VisuMax femtosecond laser system. Next, the lenticule was manually removed and the flap repositioned. The target refraction in all cases was -0.75 diopter (D).

Results: All 10 myopic eyes in the initial treatment group completed the final 6-month follow-up. The mean patient age was 39 years. The mean spherical equivalent (SE) was -4.73 +/- 1.48 (SD) preoperatively and -0.33 +/- 0.61 D 6 months postoperatively. Ninety percent of eyes were within +/-1.00 D and 40% were within +/-0.50 D of the intended correction. No eye lost 2 or more Snellen lines. Corneal topography showed large, prolate optical zones. Aberrometry showed no significant induction of higher-order aberrations. On a standardized questionnaire, all patients said they were very satisfied with the results.

Conclusions: Preliminary results indicate that FLEx [corrected] is a promising new corneal refractive procedure to correct myopia.