Purpose: To describe a standardized three-stage flap replacement protocol and report the incidence of microfolds after femtosecond laser-assisted laser in situ keratomileusis (LASIK) surgery.
Methods: A retrospective analysis of 14,374 consecutive LASIK procedures with the VisuMax femtosecond laser (Carl Zeiss Meditec) by two surgeons was conducted. As per the standardized procedure, all eyes underwent the three-stage flap replacement protocol consisting of controlled standardized minimal irrigation and flap repositioning after ablation, followed by fluorescein-controlled slit-lamp adjustments and slit-lamp adjustments on day 1 (if required). Microfold incidence was recorded at all subsequent visits and recorded by independent observers classified using a standardized 6-point grading system including whether they were refractively or visually significant.
Results: Flap thickness used was 80 to 89 µm (7.2%), 90 to 99 µm (51.7%), 100 to 109 µm (17.8%), and 110 to 130 µm (23.2%). Slit-lamp adjustment at day 1 was performed in 956 eyes (6.77%), with the highest incidence in 80 to 89 µm flaps (27.6%). A flap slip occurred in 23 eyes (0.16%) and was managed at the slit lamp for 21 eyes and in the operating room for 2 eyes. At 3 months after surgery, trace microfolds were present in 158 eyes (1.10%), grade 1 in 26 eyes (0.184%), and grade 2 in 2 eyes (0.016%). Grade 1 microfold incidence per flap thickness group was 39.1% for 80 to 89 µm, 30.4% for 90 to 99 µm, 13% for 100 to 109 µm, and 17.4% for 110 to 130 µm. No eyes required a flap lift for microfolds in the operating room. Multivariate regression analysis found microfold incidence to be higher for thinner flaps, higher correction, and larger optical zone.
Conclusions: The three-stage protocol for flap positioning and management resulted in a low incidence of clinically visible microfolds and no visually significant microfolds. Day 1 slit-lamp adjustment was required more frequently in ultra-thin 80 to 89 µm flaps. .
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