Comparison of FDA-Reported Visual and Refractive Outcomes of the Toric ICL Lens, SMILE, and Topography-Guided LASIK for the Correction of Myopia and Myopic Astigmatism.

PURPOSE: To compare U.S. Food and Drug Administration (FDA)-reported visual and refractive outcomes following surgical correction of myopia and myopic astigmatism using the Visian Toric Implantable Collamer Lens (STAAR Surgical, Monrovia, CA) (Toric ICL), small incision lenticule extraction (SMILE), and topography-guided laser in situ keratomileusis (TG-LASIK).

METHODS

FDA summary of safety and effectiveness data (SSED) were analyzed for each of the three platforms. Primary outcomes measured were efficacy, safety, stability, and accuracy of refractive correction. Stratified mean refractive spherical equivalent (MRSE) data were assessed.

RESULTS

One hundred twenty-four Toric ICL patients (210 eyes), 357 SMILE patients (357 eyes), and 212 TG-LASIK patients (249 eyes) were included. SMILE eyes had a significant improvement in postoperative uncorrected distance visual acuity with respect to preoperative corrected distance visual acuity from 3 to 12 months (P < .001), whereas TG-LASIK had no further improvement from 3 to 12 months (P = .79). For preoperative MRSE greater than 10.00 diopters (D), there was a significant difference in the percentage of eyes achieving postoperative MSRE within ±0.50 D between Toric ICL (66%) and SMILE (100%) (P < .001). SMILE was consistently more accurate than Toric ICL for cylinder within ±0.25 D (P < .001), ±0.50 D (P < .001), and ±1.00 D (P = .0014).

CONCLUSIONS

All three platforms analyzed in this study had excellent efficacy, safety, stability, and accuracy. Stratified analysis revealed that SMILE may be comparable to Toric ICL for patients with high myopia or myopic astigmatism, and SMILE may have a longer visual recovery compared to TG-LASIK than previously indicated. [J Refract Surg. 2019;35(11):699-706.].