Complications and their impact on the visual and refractive outcomes of laser in-situ keratomileusis (LASIK) vs Small incision lenticule extraction (SMILE) Corneal Surgeries - A two-armed cohort study.

Purpose To compare complication rates and their impact on visual and refractive outcomes of laser in-situ keratomileusis (LASIK) vs Small Incision Lenticule Extraction (SMILE) Corneal Surgeries in Saudi Arabia. Methods The cohort consisted of Saudi patients treated with LASIK (Gr1) and SMILE (Gr2) refractive surgeries during 2023–2024. The demographic data, preoperative ocular status, types of complications during, and one-month post-surgery outcomes were noted. Efficiency-1 was defined as achieving a 0.0 LogMAR uncorrected visual acuity (UCVA) after surgery. Efficiency-2 was post-surgery spherical equivalent of < ± 0.5D. The determinants of complications and efficiency were reviewed. Results Gr1 and Gr2 included 324 eyes of 164 and 487 eyes of 247 myopic persons. Gr1 and Gr2 were significantly different in relation to age, gender, visual impairment grades, refractive status, CCT, and UCVA. Only 3.1% of eyes had sight-threatening complications, and others were transient. Complication rates were higher in Gr1 than Gr2. [RR = 1.47, (95% CI 1.0; 2.2), P = 0.05]. The efficiency-1 in Gr1 and Gr2 was 96.6% and 96.3%. [RR = 1.02 (95% CI -5.2; 9.4), P = 0.63]. The presence of complications did not significantly affect the differential Efficiency1 in the two groups. (P = 0.06) The efficiency 2 in Gr1 and Gr2 in eyes with complications was 2% and 12% better than in eyes without complications. (P = 0.25) Conclusions Both LASIK and SMILE are highly efficient in managing refractive errors. Complications were transient. If these complications are appropriately managed, they do not result in sight-threatening disabilities.