Purpose: To evaluate the incidence, types, and outcome of microkeratome complications that occur during laser in situ keratomileusis (LASIK).
Design: Retrospective, noncomparative, case series.
Participants: Three thousand nine hundred ninety-eight eyes that underwent primary LASIK by four surgeons between November 1996 and August 1998 at a university-based refractive center.
Methods: All cases with significant microkeratome complications leading to abandonment of the LASIK procedure were identified and reviewed.
Main outcome measures: Incidence of complications, change in best corrected visual acuity (BCVA), change in refractive error, and types of complication.
Results: There were 27 complications leading to abandonment of the LASIK procedure of 3998 eyes. The overall rate of microkeratome complication was 1 in 150 (0.68%), but it was 1 in 77 (1.3%) in the surgeons' first 1000 eyes, decreasing to 1 in 250 (0.4%) in the last 1000 eyes. Of the 24 planned bilateral cases, 15 complications (63%) happened on the first operated eye. Twenty-six of 27 eyes (96%) recovered to within one line of preoperative BCVA, and one eye lost two lines. At last examination before any repeat refractive procedures, spherical equivalent manifest refraction returned to within 1 diopter (D) of its preoperative value in 18 of 19 eyes (95%), and astigmatism in 16 of 19 eyes (84%) returned to within 1 D of its preoperative value. Sixteen of 27 eyes (59%) had repeat LASIK. Two eyes had complications at repeat LASIK, one of which led to abandonment of the LASIK procedure for a second time.
Conclusions: There is a significant learning curve in the use of the microkeratome. If ablation is not performed, flap complications rarely lead to significant visual loss and generally do not result in a change in refractive error.