摘要目的:探讨基于回顾性临床数据及回归模型构建的个性化屈光参数优化方案用于飞秒激光小切口微透镜取出术（SMILE）矫正近视及散光的术后效果。方法:队列研究。前瞻性连续收集2024年8至12月在四川大学华西医院屈光中心接受基于回归模型屈光参数设计方案（Visulyze软件进行优化的列线图）的SMILE的屈光不正患者75例（148只眼）作为试验组；另在2022年12月至2023年5月期间接受传统SMILE且具备术后3个月随访数据的屈光不正患者中根据试验组患者数据采用倾向评分法匹配对照组。所有手术均使用VisuMax 500 kHz飞秒激光系统完成。采用标准对数视力表、电脑验光仪及综合验光仪检查视力与屈光度数。主要结局指标为术后3个月屈光准确性（等效球镜度数±0.50 D内的眼数占比）和散光矫正情况（残余散光度数≤0.50 D的眼数占比）；次要结局指标为有效性、安全性及预测性。结果:试验组收集到75例患者（148只眼），最终纳入67例（133只眼），脱落率10.1%；其中男性17例，女性50例，年龄28.50（24.00，32.25）岁。对照组匹配67例（133只眼），其中男性15例，女性52例，年龄29.00（26.00，31.25）岁。两组具有可比性。屈光准确性方面，等效球镜度数在±0.50 D内的眼数占比试验组为99.2%（132/133），对照组为88.7%（118/133）（ P<0.001）；残余散光度数≤0.50 D的眼数占比，试验组为99.2%（132/133），对照组为95.5%（129/133）（ P>0.05）。两组在有效性和安全性方面差异无统计学意义（均 P>0.05）：有效性方面，术后3个月裸眼视力≥20/20的眼数，试验组为129只（占比97%），对照组为132只（占比99%）；安全性方面，两组均无最佳矫正视力丢失≥2行的眼。试验组的屈光预测性显著更高，等效球镜度数和散光度数的决定系数（ R2）分别为0.978 8和0.865 3，对照组则分别为0.950 3和0.726 4。 结论:本研究基于回顾性临床数据及回归模型构建的个性化屈光参数设计方案，在SMILE中显著提高术后屈光预测的准确性和散光矫正的精度，并在术后 3 个月的随访中显示出良好的有效性和安全性。

abstractsObjective:To investigate the postoperative efficacy of a personalized refractive parameter optimization protocol constructed based on retrospective clinical data and regression models in femtosecond laser small-incision lenticule extraction (SMILE) for the correction of myopia and astigmatism.Methods:A cohort study was conducted. Prospectively and consecutively collected and enrolled 75 patients (148 eyes) with refractive errors who underwent SMILE guided by a regression model-based refractive parameter design protocol (nomogram optimized by Visulyze software) at the Refractive Center of West China Hospital, Sichuan University from August to December 2024, and designated them as the experimental group. Additionally, a control group was established using propensity score matching based on the data of the experimental group, with patients selected from those who received conventional SMILE between December 2022 and May 2023 and had complete 3-month postoperative follow-up data. All surgeries were performed using the VisuMax 500 kHz femtosecond laser system. Visual acuity and refractive power were examined using a standard logarithmic visual acuity chart, autorefractor, and phoropter. The primary outcome measures were refractive accuracy (proportion of eyes with spherical equivalent within ±0.50 D) and astigmatism correction (proportion of eyes with residual astigmatism ≤0.50 D) at 3 months postoperatively; the secondary outcome measures included efficacy, safety, and predictability.Results:The experimental group ultimately comprised 67 patients (133 eyes), yielding an attrition rate of 10.1%. There were 17 males and 50 females, with an age of 28.50 (24.00, 32.25) years. The control group included 67 matched patients (133 eyes), consisting of 15 males and 52 females, with an age of 29.00 (26.00, 31.25) years. The two groups were comparable. In terms of refractive accuracy, the proportion of eyes with spherical equivalent within ±0.50 D was 99.2% (132/133) in the experimental group and 88.7% (118/133) in the control group ( P<0.001); the proportion of eyes with residual astigmatism ≤0.50 D was 99.2% (132/133) in the experimental group and 95.5% (129/133) in the control group ( P=0.368). There were no statistically significant differences in efficacy and safety between the two groups (both P>0.05). For efficacy, the number of eyes with uncorrected visual acuity ≥20/20 at 3 months postoperatively was 129 (accounting for 97%) in the experimental group and 132 (accounting for 99%) in the control group. For safety, neither group had eyes with a loss of≥2 lines of best-corrected visual acuity. The experimental group showed significantly higher refractive predictability, with coefficients of determination ( R2) for spherical equivalent and astigmatism of 0.978 8 and 0.865 3, respectively, compared with 0.950 3 and 0.726 4 in the control group. Conclusion:In this study, the personalized refractive parameter design protocol constructed based on retrospective clinical data and regression models significantly improves the accuracy of postoperative refractive prediction and the precision of astigmatism correction in femtosecond laser small-incision lenticule extraction (SMILE), and exhibits favorable efficacy and safety during the 3-month postoperative follow-up.