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Introduction: The primary objective was to show our initial surgical single-site experience with small incision lenticule extraction (SMILE) after the official enrollment in March 2017 following Food and Drug Administration (FDA) approval for simple myopia in late 2016 in the United States and, subsequently, compare our results to the earliest and most advanced generation of excimer platforms for laser-assisted in situ keratomileusis (LASIK) surgery.Methods: This was a retrospective single-site study of 68 eyes from 35 patients who had SMILE surgery. The patients’ preoperative and postoperative uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest sphere, manifest cylinder, intraoperative complications, and preoperative and postoperative visual symptoms were collected. We compared our findings to the results from the FDA SMILE study, and to the three earliest (1999-2000) and three of the most updated (2013-2016) platforms for LASIK.Results: The cumulative UDVA was 20/20 and 20/40 or better in 74% and 100% of patients, respectively. The intended target refraction was within ± 0.5 and ± 1.00 D in 80% and 93% of cases, respectively. The prevalence of dry eyes decreased by nearly half from 1-week to the 6-month postoperative interval. Patients noted improvement in glare (17%), halos (17%), fluctuation (25%), and depth perception (8%) at the 6-month interval compared to preoperative levels.Conclusions: This study’s findings are consistent with current SMILE reports. Notably, the results are superior to the earliest generation of LASIK, however inferior to the latest excimer platforms. SMILE does meet the efficacy and safety criteria met by FDA; however, there is a definite need for further improvement to reach the superior refractive outcomes produced by the latest generation of LASIK platforms. [ABSTRACT FROM AUTHOR]

Purpose: To compare and analyze the differences in visual outcomes between Visx iDesign Advanced WaveScan Studio™ System, Alcon Wavelight Allegro Topolyzer and Nidek EC-5000 using Final Fit™ Custom Ablation Treatment Software from the submitted summary of safety and effectiveness of the US Food and Drug Administration (FDA) data. Methods: In this retrospective comparative study, 334 eyes from Visx iDesign, 212 eyes from Alcon Contour, and 135 eyes from Nidek CATz platforms were analyzed for primary and secondary visual outcomes. These outcomes were compared via side-by-side graphical and tabular representation of the FDA data. Statistical significance was calculated when appropriate to assess differences. A P-value <0.05 was considered statistically significant. Results: The mean postoperative uncorrected distance visual acuity (UDVA) at 12 months was 20/19.25±8.76, 20/16.59±5.94, and 20/19.17±4.46 for Visx iDesign, Alcon Contoura, and Nidek CATz, respectively. In at least 90% of treated eyes at 3 months and 12 months, all three lasers showed either no change or a gain of corrected distance visual acuity (CDVA). Mesopic contrast sensitivity at 6 months showed a clinically significant increase of 41.3%, 25.1%, and 10.6% for eyes using Visx iDesign, Alcon Contoura, and Nidek CATz, respectively. Photopic contrast sensitivity at 6 months showed a clinically significant increase of 19.2%, 31.9%, and 10.6% for eyes using Visx iDesign, Alcon Contoura, and Nidek CATz, respectively. Conclusion: FDA data for the three platforms shows all three were excellent with respect to efficacy, safety, accuracy, and stability. However, there are some differences between the platforms with certain outcome measurements. Overall, patients using all three lasers showed significant improvements in primary and secondary visual outcomes after LASIK surgery. [ABSTRACT FROM AUTHOR]