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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