title: Randomized prospective clinical study comparing induced aberrations with IntraLase and Hansatome flap creation in fellow eyes: potential impact on wavefront-guided laser in situ keratomileusis.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Private practice refractive surgery center, Irvine, California, USA.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Coastal Vision Medical Group, Inc., University of California Irvine, Irvine, California, USA. dr.tran@coastallaservision.com
authors.forename: Dan B
authors.initials: DB
authors.lastname: Tran
authors.forename: Melvin A
authors.initials: MA
authors.lastname: Sarayba
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Bor
authors.forename: Carrie
authors.initials: C
authors.lastname: Garufis
authors.forename: Yi-Jing
authors.initials: YJ
authors.lastname: Duh
authors.forename: Charles R
authors.initials: CR
authors.lastname: Soltes
authors.forename: Tibor
authors.initials: T
authors.lastname: Juhasz
authors.forename: Ron M
authors.initials: RM
authors.lastname: Kurtz
mesh_terms: D000328:Adult; D001251:Astigmatism / Q000503:physiopathology / Q000601:surgery; D003319:Corneal Stroma / Q000601:surgery*; D019781:Corneal Topography; D005260:Female; D006801:Humans; D006956:Hyperopia / Q000209:etiology*; D020731:Keratomileusis, Laser In Situ; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D012029:Refraction, Ocular / Q000502:physiology; D013524:Surgical Flaps / Q000009:adverse effects*; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology