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

J Cataract Refract Surg. 2008 Sep;34(9):1513-20. doi: 10.1016/j.jcrs.2008.05.033.


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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Corneal Stroma / surgery*
  • Corneal Surgery, Laser / methods*
  • Corneal Topography
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Humans
  • Intraocular Pressure
  • Lasers, Excimer / adverse effects
  • Lasers, Excimer / therapeutic use
  • Male
  • Middle Aged
  • Myopia / surgery*
  • Prospective Studies
  • Surgical Flaps*
  • Surveys and Questionnaires
  • Treatment Outcome
  • Visual Acuity / physiology