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<p>To compare 3-month visual acuity and refractive outcome accuracy after keratorefractive lenticule extraction (KLEx) when cycloplegic refraction (CR) versus manifest refraction (MR) is used as the input for the VISULYZE data-driven nomogram in SMILE 4.0 procedures. This single-center prospective comparative cohort study included 245 eyes from 144 patients (mean age 27.0 ± 7.4 years) undergoing SMILE 4.0 using the VisuMax 500 platform. Eyes were prospectively and consecutively assigned to either the CR group (134 eyes) or the MR group (111 eyes) based on a prospective, time-based alternating schedule. The primary outcome was the 3-month spherical equivalent (SE). Secondary endpoints included uncorrected and corrected distance visual acuity, as well as astigmatic vector metrics. Preoperatively, MR spherical equivalent was significantly more myopic than CR spherical equivalent (mean difference − 0.27 D, 95% CI:-0.35 to -0.19D, <i>P</i> &lt; 0.001). At 3 months, the CR group demonstrated greater accuracy in sphere (<i>P</i> = 0.002) and SE (<i>P</i> = 0.005). SE within ± 0.50 D was achieved in 96.3% of eyes in the CR group compared with 92.8% in the MR group. In the CR4.0 group, 99.3% of eyes achieved uncorrected distance visual acuity (UDVA) ≥ 20/20 versus 93.7% in the MR4.0 group (<i>P</i> = 0.021). UDVA equal to or better than preoperative corrected distance visual acuity(CDVA) was achieved in 97.8% versus 92.8%. The CR group also achieved greater astigmatic correction precision, with significantly lower DV (0.11 ± 0.12 D vs. 0.17 ± 0.19 D, <i>P</i> = 0.003), IS (0.15 ± 0.16 vs. 0.23 ± 0.23, <i>P</i> = 0.001), and CI (1.01 ± 0.22 vs. 1.10 ± 0.31, <i>P</i> = 0.009). Our research demonstrates that using cycloplegic refraction as the surgical input for VISULYZE-guided KLEx (SMILE 4.0) was associated with better refractive predictability and astigmatic correction precision in this cohort. CR reduces the systematic myopic bias associated with manifest refraction and provides a more stable baseline for nomogram planning. Future studies will involve larger-sample, randomized controlled, multicenter investigations to confirm these findings.</p>

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Short-term predictability of data-driven SMILE 4.0 nomograms for myopia: cycloplegic versus manifest refraction

  • 期刊论文

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  • 发表日期：

    2026年8月2日

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  • Mingyan Wang,
  • Hongyue Wu,
  • Min Wang,
  • Yuanlin Zhou,
  • Jing Zhang,
  • Yuehua Zhou

摘要

To compare 3-month visual acuity and refractive outcome accuracy after keratorefractive lenticule extraction (KLEx) when cycloplegic refraction (CR) versus manifest refraction (MR) is used as the input for the VISULYZE data-driven nomogram in SMILE 4.0 procedures. This single-center prospective comparative cohort study included 245 eyes from 144 patients (mean age 27.0 ± 7.4 years) undergoing SMILE 4.0 using the VisuMax 500 platform. Eyes were prospectively and consecutively assigned to either the CR group (134 eyes) or the MR group (111 eyes) based on a prospective, time-based alternating schedule. The primary outcome was the 3-month spherical equivalent (SE). Secondary endpoints included uncorrected and corrected distance visual acuity, as well as astigmatic vector metrics. Preoperatively, MR spherical equivalent was significantly more myopic than CR spherical equivalent (mean difference − 0.27 D, 95% CI:-0.35 to -0.19D, P < 0.001). At 3 months, the CR group demonstrated greater accuracy in sphere (P = 0.002) and SE (P = 0.005). SE within ± 0.50 D was achieved in 96.3% of eyes in the CR group compared with 92.8% in the MR group. In the CR4.0 group, 99.3% of eyes achieved uncorrected distance visual acuity (UDVA) ≥ 20/20 versus 93.7% in the MR4.0 group (P = 0.021). UDVA equal to or better than preoperative corrected distance visual acuity(CDVA) was achieved in 97.8% versus 92.8%. The CR group also achieved greater astigmatic correction precision, with significantly lower DV (0.11 ± 0.12 D vs. 0.17 ± 0.19 D, P = 0.003), IS (0.15 ± 0.16 vs. 0.23 ± 0.23, P = 0.001), and CI (1.01 ± 0.22 vs. 1.10 ± 0.31, P = 0.009). Our research demonstrates that using cycloplegic refraction as the surgical input for VISULYZE-guided KLEx (SMILE 4.0) was associated with better refractive predictability and astigmatic correction precision in this cohort. CR reduces the systematic myopic bias associated with manifest refraction and provides a more stable baseline for nomogram planning. Future studies will involve larger-sample, randomized controlled, multicenter investigations to confirm these findings.