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

Abstract

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.]

Comparison of corneal optical quality after SMILE, wavefront-optimized LASIK and topography-guided LASIK for myopia and myopic astigmatism

“…The current study found no signi cant differences in postoperative UDVA or CDVA among SMILE, WFO and TCAT groups, showing that the three procedures were comparably effective and safe. The majority of previous studies demonstrated the similar results [9][10][11][12][13][14] . A randomized, paired-eye study found that SMILE achieved similar results as WFO LASIK in terms of e cacy index (0.97±0.20 vs. 0.99±0.20; P = 0.56), UDVA of 20/40 or better (100% vs. 100%; P = 1.0), and UDVA of 20/20 or better (84% vs. 87%; P = 0.63) 9 .…”

“…The present study found that postoperative MRSE at 1 and 6 months was similar among the three groups, but the 1-month postoperative cylinder was signi cantly different among the three groups, with the highest mean value in the TCAT group. Most previous studies showed comparable refractive results between SMILE and WFO FS-LASIK or SMILE and TCAT FS-LASIK [9][10][11][12][13][14] . The high residual cylinder in the TCAT group of the present study was similar to our previous study 16 , which might be caused by the compensation method for TCAT design.…”

Four-Year Outcomes of Small Incision Lenticule Extraction for Extreme High Myopia and Myopic Astigmatism

“…Concerning predictability, Pedersen et al (17) determined that 78% and 90% of eyes were within ±0.50 and ±1.00 D at 3 years post-SMILE (mean SE of −7.30 D). In order to prevent under-correction, Burazovitch et al (18) employed an 8% correction factor and found that 87% (100%) of eyes were within ±0.50 D (±1.00 D) (mean SE of−7.59 D) of refraction error, while Moshirfar et al (19) found that in their experience, 100% of eyes that had undergone SMILE were within ±0.50 D, relative to just 66% of Toric implantable Collamer lens (ICL)-treated eyes (mean SE > −10.0 D). This led the authors to conclude that SMILE is superior to Toric ICL, although it is important to note that the SMILE group in this study was relatively small.…”

The State of Refractive Surgery: 2021 and Beyond

“…This is good for our profession, but, most importantly, for our patients. Now more than ever, we have techniques and technology to provide safe and highly effective refractive surgery to the majority of patients for most refractive errors, [2][3][4] and increasingly effective strategies to repair unwanted outcomes when they do occur. 5,6 Since initial reports of coronavirus being found in tears and potentially transmissible via the conjunctiva, the risk of coronavirus transmission through ocular surgery has been evaluated.…”