SMILE, Topography-Guided LASIK, and Wavefront-Guided LASIK: Review of Clinical Outcomes in Premarket Approval FDA Studies

Abstract

Purpose: To review clinical outcomes of the U.S. Food and Drug Administration premarket approval (PMA) studies of the three recently approved refractive surgery platforms for the correction of spherocylindrical myopia.

Methods: Clinical outcomes and vector analysis of astigmatism were reviewed and compared between wavefront-guided laser in situ keratomileusis (LASIK) (WFG group) (STAR S4 IR with iDesign aberrometer; Johnson & Johnson Vision Care, Inc., Santa Ana, CA), topography-guided LASIK (TOPO group) (Allegretto Wave Eye-Q laser; Alcon Laboratories, Inc., Fort Worth, TX), and small incision lenticule extraction (SMILE group) (VisuMax laser; Carl Zeiss Meditec AG, Jena, Germany).

Results: The number of eyes included was 304, 249, and 334 for the SMILE, TOPO, and WFG groups, respectively. The WFG group had the highest preoperative spherical equivalent refraction (-6.21 ± 2.78 diopters [D]), followed by the SMILE (-5.39 ± 2.30 D) and TOPO (-4.61 ± 2.43 D) groups. At 6 months postoperatively, 83.7%, 88.9%, and 82.6% of eyes in the SMILE, TOPO, and WFG groups, respectively, had uncorrected distance visual acuity (UDVA) of 20/20 or better. SMILE showed slower visual recovery at early postoperative examinations, whereas the WFG group had a decrease in UDVA over time due to refractive regression. The mean refractive cylinder changed from -1.53 ± 0.70 D preoperatively to -0.22 ± 0.33 D at 6 months postoperatively in the SMILE group, -1.19 ± 1.23 to -0.19 ± 0.30 D in the TOPO group, and -1.77 ± 1.65 to -0.33 ± 0.36 D in the WFG group. With all three procedures, undercorrection of refractive cylinder was seen with increasing attempted correction.

Conclusions: All three procedures demonstrated excellent outcomes, considering differences in attempted correction between studies. No obvious superiority of one technique over the others was found in astigmatic correction. [J Refract Surg. 2019;35(11):690-698.].