Femtosecond Laser Flap Creation for Laser in situ Keratomileusis: Six-month Follow-up of Initial U.S. Clinical Series

PURPOSE: To evaluate clinical performance of a femtosecond laser for flap creation in laser in situ keratomileusis (LASIK). METHODS: A prospective, consecutive series of 208 eyes (122 patients) undergoing LASIK between June 2000 and November 2000 using a femtosecond laser for creation of the corneal flap were evaluated for the incidence of complications. A subset of 114 patients who underwent myopic procedures and who were followed for 6 months was analyzed using standard outcome measures. RESULTS: In 4 of 208 eyes (1.9%), suction was lost during the procedure, causing the flap resection to be interrupted. However, in all four of these eyes the procedure was successfully performed 5 to 45 minutes after re-applanation of the eye. No postoperative complications or adverse events were observed in any treated eye. In the subgroup of 96 eyes undergoing plano correction and followed for 6 months (preoperative spherical equivalent refraction range -0.63 to -12.40 D), 98% (94 eyes) achieved uncorrected visual acuity of 20/40 or better; 94% (90 eyes) achieved 20/30 or better, 79% (76 eyes) achieved 20/25; and 55% (53 eyes) achieved 20/20 or better--all without benefit of retreatment. CONCLUSION: Femtosecond laser corneal flap creation is a safe and effective alternative to traditional mechanical microkeratomes. Standard LASIK nomograms appeared to apply equally well to the all-laser LASIK procedures. The potential for improved flap safety, reproducibility, flexibility, as well as for additional corneal applications are now being explored.