Randomized prospective clinical study comparing induced aberrations with IntraLase and Hansatome flap creation in fellow eyes

To measure and compare the changes in objective wavefront aberration and subjective manifest refraction after laser in situ keratomileusis (LASIK) flap creation with a mechanical microkeratome and a femtosecond laser.Private practice refractive surgery center, Irvine, California, USA.This randomized prospective study comprised 9 patients (18 eyes) treated with a 2-step LASIK procedure: lamellar keratectomy with a Hansatome microkeratome (Bausch & Lomb) or the IntraLase femtosecond laser in fellow eyes followed by non-wavefront-guided (standard) excimer laser treatment with the Technolas 217A (Bausch & Lomb) excimer laser 10 weeks later. Fellow eyes were matched to within 0.75 diopter (D) sphere and 0.50 D cylinder. Patients were followed for 3 months after excimer laser treatment. Preoperative and post-flap creation wavefront aberrometry using a Hartmann-Shack aberrometer and manifest refraction were compared between the 2 groups. The same tests were performed 3 months after excimer laser ablation.Statistically significant changes were seen in defocus wavefront aberrations after Hansatome (P=.004) and IntraLase (P=.008) flap creation. A hyperopic shift in manifest refraction was noted in the Hansatome group after the creation of the corneal flap (P=.04); no statistically significant changes in manifest refraction were seen in the IntraLase group. Statistically significant changes in total higher-order aberrations (HOAs) (trefoil and quadrafoil Zernike terms) were seen after flap creation in the Hansatome group (P=.02). No significant changes in HOAs were noted after flap creation in the IntraLase group. After the flap was relifted and standard excimer laser ablation was performed, a statistically significant increase in coma occurred in the Hansatome group (P=.008). Standard refractive outcomes in the 2 groups were similar.The creation of the LASIK flap alone can modify the eye's optical characteristics in low-order aberrations and HOAs. A significant increase in HOAs was seen in the Hansatome group but not in the IntraLase group. This may have significant clinical implications in wavefront-guided LASIK treatments, which are based on measurements made before flap creation.