Longitudinal comparison of outcomes after sub-Bowman keratomileusis and laser in situ keratomileusis: randomized, double-masked study.

Abstract

To compare the outcomes of sub-Bowman keratomileusis (100-μm flap) and laser in situ keratomileusis (LASIK) (120-μm flap) using 150-kHz femtosecond laser. Randomized, double-masked, contralateral clinical trial. One hundred patients (200 eyes) with myopia or myopic astigmatism were included. Postoperative examinations were performed at week 1 and months 1, 3, 6, and 12. Main outcome measures included postoperative uncorrected (UCVA) and best-corrected distance visual acuity (BCVA); manifest refraction spherical equivalent; efficacy and safety indices; corneal thickness; and complications. The mean age of patients was 33.9 ± 7.9 years. Overall, the preoperative UCVA, BCVA, and manifest refraction spherical equivalent were 1.349 ± 0.332, -0.022 ± 0.033, and -5.81 ± 1.61 diopters, respectively. No significant difference was observed in preoperative (P ≥ .226) or intraoperative parameters (P ≥ .452) between both groups, except residual stromal thickness (P < .001). The UCVA, manifest refraction spherical equivalent, and central corneal thickness stabilized by 1 week, while the thinnest corneal thickness stabilized by 3 months postoperatively. There was no significant difference between both groups for any parameter during all follow-up visits (P ≥ .132) except the 3-month safety index, which was better in the sub-Bowman keratomileusis group (P = .007). Soft opaque bubble layer was noted intraoperatively in 12 cases (7, 100-μm group; 5, 120-μm group; P = .577). No postoperative complications were observed. Our study did not find any differences in the visual and refractive outcomes between femtosecond-assisted sub-Bowman keratomileusis and LASIK. Both surgeries resulted in quick visual recovery as early as 1 week postoperatively.