Functional Optical Zone and Centration Following SMILE and LASIK: A Prospective, Randomized, Contralateral Eye Study.

PURPOSE: To compare centration and functional optical zone (FOZ) after small incision lenticule extraction (SMILE) and femtosecond laser-assisted in situ keratomileusis (LASIK). METHODS: In this prospective, randomized, single-masked, paired-eyed, clinical trial, 70 patients received SMILE in one eye and LASIK in the other eye for myopia and myopic astigmatism. FOZ was calculated using custom software on 3-month postoperative refractive power maps (Pentacam HR; Oculus Optikgerate GmbH, Wetzlar, Germany). Programmed treatment area was defined as the total area of the programmed OZ plus the transition zone. Centration was evaluated by the linear distance between FOZ centroid and the pupil center and the corneal apex. RESULTS: The average preoperative spherical equivalent (-5.38 +/- 1.65 vs -5.45 +/- 1.61 diopters [D]), postoperative spherical equivalent (0.05 +/- 0.39 vs 0.06 +/- 0.39 D), uncorrected distance visual acuity (0.01 +/- 0.13 vs 0.00 +/- 0.08 logMAR), and corrected distance visual acuity (-0.07 +/- 0.10 vs -0.07 +/- 0.10 logMAR) were comparable in SMILE- and LASIK-treated eyes of the 60 patients with complete datasets (P > .419). Postoperative increase in spherical aberration was lower in SMILE than in LASIK (0.08 +/- 0.16 vs 0.17 +/- 0.18 mu m, P = .002). The FOZ area was significantly larger in SMILE than in LASIK (30.25 +/- 3.60 vs 29.21 +/- 3.72 mm(2)), despite the smaller programmed OZ diameter (6.48 +/- 0.08 vs 6.52 +/- 0.11 mm) and smaller programmed treatment area (33.87 +/- 0.81 vs 46.30 +/- 2.61 mm(2), P < .037). Pupil centration (0.43 +/- 0.21 vs 0.41 +/- 0.22 mm) and apex centration (0.48 +/- 0.24 vs 0.48 +/- 0.22 mm) were comparable between SMILE and LASIK (P > .694). CONCLUSIONS: SMILE created a larger FOZ than LASIK, despite the smaller programmed OZ. This may be due to a difference in the biomechanical response between the two procedures. Visual outcome and centration were comparable between SMILE and LASIK.