Purpose: To assess the efficacy, safety, and predictability of the VisuMax femtosecond laser (Carl Zeiss Meditec).
Methods: In a prospective, multicenter clinical trial, 32 eyes of 17 patients underwent LASIK and flap creation with the VisuMax femtosecond laser and ablation with the MEL 80 excimer laser (Carl Zeiss Meditec). Mean patient age was 35 years (range: 23 to 52 years). Mean preoperative spherical equivalent refraction was -4.04 +/- 1.39 diopters (D) (range: -1.50 to -7.25 D), and the planned flap thickness was 110, 120, 140, and 150 microm.
Results: At the 3-month postoperative examination, all eyes had best spectacle-corrected visual acuity of 20/25 and uncorrected visual acuity (UCVA) of 20/40; 91% of eyes reached UCVA of 20/20 or better. Ninety-four percent of eyes were within +/- 0.50 D of the planned correction. Complications were limited to one case of suction loss, and no other adverse events were noted at 3 months. The flaps were planar and the mean achieved central flap thickness was 118 +/-9.2 microm for an attempted thickness of 120 microm.
Conclusions: The investigators achieved LASIK outcomes exceeding the US Food and Drug Administration guidelines for refractive procedures in this series of myopic eyes using the VisuMax femtosecond laser and MEL 80 excimer laser. The curved contact lens of the applanation glass combined with low suction permitted continuous fixation during treatment.