To compare clinical outcomes between fellow eyes randomized to femtosecond laser–created flaps (femtosecond group) or mechanical keratome–created flaps (mechanical group) during wavefront-guided laser in situ keratomileusis.
Prospective, randomized, comparative clinical study.
Main Outcome Measures
Efficacy, safety, predictability, stability, changes in corneal optical aberrations, and low-contrast visual acuity before and 1 week and 1, 3, 6, and 12 months after surgery.
Forty-three patients underwent evaluation in this study. One month after surgery, the mean (SD) spherical equivalent was −0.15 (0.30) diopters (D) for the femtosecond group and −0.12 (0.29) D for the mechanical group (differences were not statistically significant). Twelve months after surgery, 39 eyes (98%) in the femtosecond group had uncorrected visual acuity of 20/20 or better compared with 37 (95%) in the mechanical group. The femtosecond group had fewer high-order, spherical, and coma aberrations and more trefoil aberrations than the mechanical group at 1 month (P = .55), 3 months (P = .05), 6 months (P = .33), and 12 months (P = .48) after surgery. At 25% contrast, the femtosecond group had gains at 1 month (P = .01) and 6 months (P = .008) after surgery.
Twelve months after keratomileusis, clinical outcomes were similar for both groups.