Abstract
The aim of this study was to compare outcomes of topography-guided laser-assisted in situ keratomileusis (TG-LASIK) and small incision lenticule extraction (SMILE®) for correcting myopia and myopic astigmatism. In this prospective, randomized contralateral study, 34 patients (68 eyes) received TG-LASIK in one eye, and SMILE in their fellow eye. Efficacy, safety, predictability, higher-order aberrations, corneal tomography, biomechanics, and patient-reported outcomes (PROs) were assessed preoperatively and up to 3months postoperatively. Both platforms showed comparable efficacy at 3months (TG-LASIK 1.08 ± 0.19; SMILE 0.98 ± 0.17, p = 0.055). However, TG-LASIK demonstrated quicker visual recovery, with 63% and 89% achieving uncorrected distance visual acuity (UDVA) of 20/16 or better at 1day and 1week, respectively, compared to SMILE (34% and 63%; p < 0.05). Safety index at 3months did not significantly differ between TG-LASIK and SMILE (p = 0.223). TG-LASIK and SMILE had 44% and 56% of eyes within 0.13D of spherical equivalent (SEQ) target, respectively. SMILE induced more total higher-order aberrations (HOAs), vertical coma, and oblique trefoil than TG-LASIK at 3months (p < 0.05). Both platforms showed similar increases in epithelial remodeling, but SMILE induced thicker epithelium than TG-LASIK at the 7.0-mm nasal zonal area. No significant differences were found in corneal hysteresis (CH) or corneal resistance factor (CRF) at 3months (p > 0.05). Reported symptoms of glare, halos, rings, starbursts, or dry eye did not significantly differ between groups at 3months (p > 0.05). Overall, 59% of patients preferred their TG-LASIK treated eye at 1month, but 65% of patients had no specific eye preference at 3months. TG-LASIK and SMILE demonstrate excellent and comparable efficacy, safety, and predictability at 3months, but TG-LASIK offers faster postoperative visual recovery at 1day and 1week. TG-LASIK induces fewer HOAs than SMILE, but both procedures affect corneal biomechanics similarly. ClincialTrials.gov identifier, NCT05611294.
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