Prospective randomized trial of wavefront-guided laser in situ keratomileusis with the CustomCornea and CustomVue laser systems.

PURPOSE: To compare visual function, safety, and higher-order aberrations (HOAs) after wavefront-guided laser in situ keratomileusis (LASIK) with the LadarVision CustomCornea (Alcon Laboratories, Inc.) and Star S4 CustomVue (Visx) laser systems.

SETTING: John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA.

METHODS: Seventy-eight eyes of 39 patients with myopia with or without astigmatism were randomized for LASIK treatment in 1 eye with the CustomCornea laser; the other eye was treated with the CustomVue laser. Patients were followed for 6 months after surgery. The primary outcome measures were uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), manifest refraction, and changes in HOAs.

RESULTS: At 6 months, the mean logarithm of the minimum angle of resolution (logMAR) UCVA was -0.0135 +/- 0.07 (SD) in the CustomVue group and 0.0417 +/- 0.12 in the CustomCornea group (P = .023). Eighty-eight percent of eyes in the CustomVue group had 20/20 or better UCVA compared with 67% in the CustomCornea group (P<.02). At 6 months, 91% of eyes in the CustomVue group and 79% in the CustomCornea group were within +/-0.50 diopter (D) of emmetropia (P<.1); 88% and 50%, respectively, were within +/-0.25 D (P<.001). Both platforms led to a small increase in total HOAs. The CustomVue system reduced trefoil and induced less of an increase in total HOAs, whereas the CustomCornea platform increased trefoil but induced less of an increase in spherical aberrations and coma.

CONCLUSIONS: Both laser systems were effective, safe, and predictable. Wavefront-guided LASIK with the CustomVue system resulted in better visual acuity, with more eyes having 20/20 acuity than in the CustomCornea group.