PURPOSE: To compare visual outcomes and flap stability of LASIK with ultrathin 80- and 120-μm flaps created with a VisuMax femtosecond laser (Carl Zeiss Meditec, Jena, Germany) for moderate to high myopia and to evaluate the effect of corneal flap thickness on outcomes. METHODS: In a prospective contralateral eye study, 36 consecutive patients (72 eyes) underwent bilateral LASIK for myopia ranging from -2.00 to -10.00 diopters using the VisuMax femtosecond laser and MEL-80 excimer laser (Carl Zeiss Meditec). One eye of each patient was randomized to have the 80-μm flap and the other to the 120-μm flap created with 200-kHz VisuMax femtosecond laser. Preoperative and postoperative tests included visual acuity, manifest refraction, contrast sensitivity, and flap thickness measured by anterior segment optical coherence tomography. Main outcomes and complications were checked at postoperative 1 week and 1, 3, and 6 months. RESULTS: There were no differences in visual outcome, residual refractive error, or contrast sensitivity between groups during follow-up, except for better uncorrected visual acuity at postoperative 1 day in the 120-μm group. Mean standard deviations of measured flap thickness during follow-up ranged from 3.16 to 3.80 μm in both groups. Opaque bubble layer, a unique complication in femtosecond LASIK, was more frequent in the 80-μm group (7 of 36: 19%) than in the 120-μm flap group (3 of 36: 8%) without a statistically significant difference (P = .301) and was related to thicker central cornea and steeper keratometric value, although it did not influence clinical results. Comparison of the intended versus achieved correction showed no significant differences between groups. CONCLUSIONS: LASIK using the VisuMax femtosecond laser supplied good clinical results and flap reproducibility in both the 80- and 120-μm flap groups. Patients with relatively thin cornea may benefit from 80-μm flap LASIK. Copyright 2013, SLACK Incorporated.
RCT Entities:
PURPOSE: To compare visual outcomes and flap stability of LASIK with ultrathin 80- and 120-μm flaps created with a VisuMax femtosecond laser (Carl Zeiss Meditec, Jena, Germany) for moderate to high myopia and to evaluate the effect of corneal flap thickness on outcomes. METHODS: In a prospective contralateral eye study, 36 consecutive patients (72 eyes) underwent bilateral LASIK for myopia ranging from -2.00 to -10.00 diopters using the VisuMax femtosecond laser and MEL-80 excimer laser (Carl Zeiss Meditec). One eye of each patient was randomized to have the 80-μm flap and the other to the 120-μm flap created with 200-kHz VisuMax femtosecond laser. Preoperative and postoperative tests included visual acuity, manifest refraction, contrast sensitivity, and flap thickness measured by anterior segment optical coherence tomography. Main outcomes and complications were checked at postoperative 1 week and 1, 3, and 6 months. RESULTS: There were no differences in visual outcome, residual refractive error, or contrast sensitivity between groups during follow-up, except for better uncorrected visual acuity at postoperative 1 day in the 120-μm group. Mean standard deviations of measured flap thickness during follow-up ranged from 3.16 to 3.80 μm in both groups. Opaque bubble layer, a unique complication in femtosecond LASIK, was more frequent in the 80-μm group (7 of 36: 19%) than in the 120-μm flap group (3 of 36: 8%) without a statistically significant difference (P = .301) and was related to thicker central cornea and steeper keratometric value, although it did not influence clinical results. Comparison of the intended versus achieved correction showed no significant differences between groups. CONCLUSIONS: LASIK using the VisuMax femtosecond laser supplied good clinical results and flap reproducibility in both the 80- and 120-μm flap groups. Patients with relatively thin cornea may benefit from 80-μm flap LASIK. Copyright 2013, SLACK Incorporated.