Purpose: To report the 6-month results of a new method of refractive correction, femtosecond lenticule extraction (FLEx), and the preliminary outcomes in the first 108 eyes.
Methods: In this prospective study, a flap and a lenticule of intrastromal corneal tissue were cut simultaneously using a femtosecond laser. Thereafter, the lenticule was removed manually and the flap repositioned. One hundred and seven of 108 myopic eyes of 56 patients in the treatment group completed the final 6 months of follow-up. The patients' mean age was 35 years. The preoperative mean spherical equivalent (SE) was -4.59 +/- 1.3 diopters (D). The uncorrected visual acuity and the best spectacle-corrected visual acuity after 6 months, objective and manifest refractions, results of slit-lamp examination, the side effects, and the responses to a questionnaire are reported.
Results: Six months postoperatively, the mean SE was -0.19 +/- 0.47 D; 98.1% of treated eyes were within +/-1.0 D, and 74.8% of eyes within +/-0.5 D of the intended correction. Eight (7.4%) of 108 eyes lost one line of Snellen VA, one (0.9%) eye lost two Snellen lines, 46 eyes (43%) gained one line, ten eyes (9.3%) gained two Snellen lines, and the VA remained unchanged in 42 (39.3%) eyes. The patient responses to a standardized questionnaire indicated that 97.1% of patients were satisfied with the obtained results and would undergo the procedure again.
Conclusion: FLEx appears to be a safe and promising corneal refractive procedure for correcting myopia.