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Background. To compare the early outcome of combined SMILE and collagen crosslinking (SMILE Xtra) with SMILE. Method. Prospective, comparative interventional study of 21 eyes receiving SMILE Xtra using a low energy protocol and 32 control eyes receiving SMILE only. The outcomes were compared at 1, 3, and 6 months postoperatively. Results. Both groups had myopia with spherical equivalent refraction (SEQ) > 4.00 D. The SMILE Xtra group had thinner preoperative central corneal thickness and residual stromal bed thickness ( p < 0.021 ). At 6 months, no eyes lost more than 1 line in corrected distance visual acuity. The safety index was 0.96 ± 0.06 and 1.00 ± 0.00 in SMILE Xtra and control, respectively ( p < 0.001 ). 89% and 94% of eyes were within ±0.50 D of target refraction, respectively, with the mean error in SEQ correction being - 0.17 ± 0.26 D for SMILE Xtra and + 0.03 ± 0.25 D for control ( p = 0.021 ). The efficacy index was 0.88 ± 0.13 and 0.97 ± 0.06 , respectively ( p = 0.005 ). Conclusion. SMILE Xtra had good overall safety profile and predictability at 6 months. However, when compared with control, the safety index and efficacy index were statistically significantly lower in the early postoperative period.

Comparison of the Early Clinical Outcomes between Combined Small-Incision Lenticule Extraction and Collagen Cross-Linking versus SMILE for Myopia