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Clinical Trials |

Comparison of the Femtosecond Laser and Mechanical Keratome for Laser In Situ Keratomileusis

Annie Chan, MD; Judy Ou, MD; Edward E. Manche, MD
Arch Ophthalmol. 2008;126(11):1484-1490. doi:10.1001/archopht.126.11.1484.
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Objective  To compare clinical outcomes between fellow eyes randomized to femtosecond laser–created flaps (femtosecond group) or mechanical keratome–created flaps (mechanical group) during wavefront-guided laser in situ keratomileusis.

Design  Prospective, randomized, comparative clinical study.

Main Outcome Measures  Efficacy, safety, predictability, stability, changes in corneal optical aberrations, and low-contrast visual acuity before and 1 week and 1, 3, 6, and 12 months after surgery.

Results  Forty-three patients underwent evaluation in this study. One month after surgery, the mean (SD) spherical equivalent was −0.15 (0.30) diopters (D) for the femtosecond group and −0.12 (0.29) D for the mechanical group (differences were not statistically significant). Twelve months after surgery, 39 eyes (98%) in the femtosecond group had uncorrected visual acuity of 20/20 or better compared with 37 (95%) in the mechanical group. The femtosecond group had fewer high-order, spherical, and coma aberrations and more trefoil aberrations than the mechanical group at 1 month (P = .55), 3 months (P = .05), 6 months (P = .33), and 12 months (P = .48) after surgery. At 25% contrast, the femtosecond group had gains at 1 month (P = .01) and 6 months (P = .008) after surgery.

Conclusion  Twelve months after keratomileusis, clinical outcomes were similar for both groups.

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Figure 1.

Changes in best-corrected visual acuity (BCVA) (safety) 12 months after laser in situ keratomileusis in both groups. Groups are described in the “Methods” section.

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Figure 2.

Intended vs achieved correction of spherical equivalent (SphEq) (predictability) 12 months after laser in situ keratomileusis in both groups. Groups are described in the “Methods” section. D indicates diopter; MRSphEq, manifest SphEq.

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Figure 3.

Time course of the spherical equivalent and standard deviation after laser in situ keratomileusis for both groups. Groups are described in the “Methods” section. D indicates diopter.

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Figure 4.

Change in higher order aberrations (HOAs) 12 months from baseline. Bars and lines represent means and SDs, respectively. Groups are described in the “Methods” section.

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Figure 5.

Contrast sensitivity visual acuity changes from baseline at 5% contrast and 25% contrast 12 months after laser in situ keratomileusis for both groups. The 12-month postoperative examination included 23 eyes in the femtosecond group (F) and 22 in the mechanical group (M). Groups are described in the “Methods” section.

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Figure 6.

Postoperative patient eye preference. Groups are described in the “Methods” section.

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