Twelve-Month Visual, Refractive, and Ocular Wavefront Outcomes of SmartSight KLEx, Pooling Original and NOVA Workflows, on the SCHWIND ATOS: A Single-Surgeon Cohort Study

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To report the visual, refractive, astigmatic, and ocular higher-order aberration (HOA) outcomes of keratorefractive lenticule extraction (KLEx) with the SCHWIND ATOS femtosecond laser platform in a large single-surgeon cohort. In this retrospective consecutive series, 2518 eyes of 1292 patients underwent single-surgeon KLEx (SmartSight procedure, SCHWIND ATOS platform) for myopia or myopic astigmatism. Data from two treatment workflows were pooled: the original SmartSight lenticule workflow (1886 eyes) and, from 2025, SmartSight NOVA with CenTrax-assisted centration (632 eyes); workflow-stratified outcomes are reported separately in Table 4. Refraction, uncorrected and corrected distance visual acuity ( (UDVA and CDVA, respectively), and pyramidal-wavefront aberrometry (OSIRIS-T corneal topographer and ocular aberrometer; 4 and 6 mm) were recorded for 12 months of follow-up (primary; 3 months secondary). The target was emmetropia; astigmatism used the Alpins vector method. Denominators were endpoint specific, and inference was clustered by patient. Mean preoperative spherical equivalent (SEQ) was − 3.86 ± 1.93 diopters (D). At 12 months post-procedure, in 830 eyes with a complete acuity record and 930 with paired SEQ, mean SEQ was − 0.04 ± 0.31 D, with 92.9% within ± 0.50 D and 98.2% within ± 1.00 D; achieved correction tracked attempted (slope 0.98). UDVA was 20/20 or better in 94.9% of eyes, and 94% saw uncorrected at least as well as preoperatively corrected. One of 830 eyes lost exactly two CDVA lines; none lost more than two. Astigmatic outcomes are documentation dependent: among eyes with an explicitly recorded postoperative cylinder, 68.6% were within 0.50 D, whereas the whole-cohort estimate (89.9%) rests on the unvalidated convention that a blank cylinder field denotes plano, and postoperative axis was not captured, so vector indices are exploratory. Paired mean SEQ changes from month 3 through month 12 were < 0.05 D. An enhancement-as-failure composite (any enhancement before 12 months counted as failure) was met by 89.6% of eyes. In a paired wavefront subset (412 eyes), HOA induction was modest and coma-dominated: total ocular HOA rose from 0.14 to 0.18 µm at 4 mm (P < 0.001) and was not significantly changed at 6 mm (P = 0.10). Preoperative spherical aberration was positive; ocular spherical aberration decreased modestly while total corneal spherical aberration was preserved at 12 months (P = 0.59). In this large single-surgeon series, pooling data from the original SmartSight workflow and the SmartSight NOVA, KLEx on the SCHWIND ATOS delivered accurate, safe, and stable 12-month outcomes with excellent uncorrected vision and only modest higher-order aberration induction. As a single-surgeon experience using an evolving offset and two treatment workflows that are temporally confounded with each other and with surgical experience, these findings describe a descriptive association between the offset strategy and favorable outcomes rather than validation of a fixed nomogram or of SmartSight NOVA specifically; the current + 0.75 D offset was not represented at one year and requires prospective, workflow-controlled validation. Laser eye surgery can correct short-sightedness (myopia) and astigmatism so that people rely less on glasses or contact lenses. A newer flap-free method removes a thin disc of tissue from inside the cornea through a small opening. In this study, we examined the 1-year results of this method performed by a single experienced surgeon with the SCHWIND ATOS femtosecond laser platform, in a large series of 2518 eyes treated over almost 4 years. One year after surgery, the correction was very accurate: about 93 of every 100 eyes were within half a diopter of the intended target, and roughly 95 of every 100 eyes could see 20/20 or better without glasses. A meaningful loss of best-corrected vision was very rare, and results were stable through the first year. The surgery increased only modestly the small natural optical imperfections of the eye. This study pooled the results of two versions of the treatment: the original method used throughout the study, and a newer version introduced partway through the study called SmartSight NOVA, which integrates automated tracking of eye position and movement. Because the two versions were not compared side by side under the same conditions and because the surgeon's personal adjustment formula also changed over the same period, no conclusions can be drawn on whether the newer SmartSight NOVA version performed differently from the original. Consequently, the results should be confirmed by other surgeons and centers, ideally comparing both versions directly, before the same settings are more widely adopted. Overall, the findings show that this flap-free method can deliver accurate, safe, and stable vision correction in routine high-volume practice.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.