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Abstract：
BACKGROUND: The aim of this study was to compare outcomes of topography-guided laser-assisted in situ keratomileusis (TG-LASIK) and small incision lenticule extraction (SMILE®) for correcting myopia and myopic astigmatism.
METHODS: In this prospective, randomized contralateral study, 34 patients (68 eyes) received TG-LASIK in one eye, and SMILE in their fellow eye. Efficacy, safety, predictability, higher-order aberrations, corneal tomography, biomechanics, and patient-reported outcomes (PROs) were assessed preoperatively and up to 3 months postoperatively.
RESULTS: Both platforms showed comparable efficacy at 3 months (TG-LASIK 1.08 ± 0.19; SMILE 0.98 ± 0.17, p = 0.055). However, TG-LASIK demonstrated quicker visual recovery, with 63% and 89% achieving uncorrected distance visual acuity (UDVA) of 20/16 or better at 1 day and 1 week, respectively, compared to SMILE (34% and 63%; p < 0.05). Safety index at 3 months did not significantly differ between TG-LASIK and SMILE (p = 0.223). TG-LASIK and SMILE had 44% and 56% of eyes within 0.13 D of spherical equivalent (SEQ) target, respectively. SMILE induced more total higher-order aberrations (HOAs), vertical coma, and oblique trefoil than TG-LASIK at 3 months (p < 0.05). Both platforms showed similar increases in epithelial remodeling, but SMILE induced thicker epithelium than TG-LASIK at the 7.0-mm nasal zonal area. No significant differences were found in corneal hysteresis (CH) or corneal resistance factor (CRF) at 3 months (p > 0.05). Reported symptoms of glare, halos, rings, starbursts, or dry eye did not significantly differ between groups at 3 months (p > 0.05). Overall, 59% of patients preferred their TG-LASIK treated eye at 1 month, but 65% of patients had no specific eye preference at 3 months.
CONCLUSIONS: TG-LASIK and SMILE demonstrate excellent and comparable efficacy, safety, and predictability at 3 months, but TG-LASIK offers faster postoperative visual recovery at 1 day and 1 week. TG-LASIK induces fewer HOAs than SMILE, but both procedures affect corneal biomechanics similarly.
BACKGROUND: ClincialTrials.gov identifier, NCT05611294.
METHODS: In this prospective, randomized contralateral study, 34 patients (68 eyes) received TG-LASIK in one eye, and SMILE in their fellow eye. Efficacy, safety, predictability, higher-order aberrations, corneal tomography, biomechanics, and patient-reported outcomes (PROs) were assessed preoperatively and up to 3 months postoperatively.
RESULTS: Both platforms showed comparable efficacy at 3 months (TG-LASIK 1.08 ± 0.19; SMILE 0.98 ± 0.17, p = 0.055). However, TG-LASIK demonstrated quicker visual recovery, with 63% and 89% achieving uncorrected distance visual acuity (UDVA) of 20/16 or better at 1 day and 1 week, respectively, compared to SMILE (34% and 63%; p < 0.05). Safety index at 3 months did not significantly differ between TG-LASIK and SMILE (p = 0.223). TG-LASIK and SMILE had 44% and 56% of eyes within 0.13 D of spherical equivalent (SEQ) target, respectively. SMILE induced more total higher-order aberrations (HOAs), vertical coma, and oblique trefoil than TG-LASIK at 3 months (p < 0.05). Both platforms showed similar increases in epithelial remodeling, but SMILE induced thicker epithelium than TG-LASIK at the 7.0-mm nasal zonal area. No significant differences were found in corneal hysteresis (CH) or corneal resistance factor (CRF) at 3 months (p > 0.05). Reported symptoms of glare, halos, rings, starbursts, or dry eye did not significantly differ between groups at 3 months (p > 0.05). Overall, 59% of patients preferred their TG-LASIK treated eye at 1 month, but 65% of patients had no specific eye preference at 3 months.
CONCLUSIONS: TG-LASIK and SMILE demonstrate excellent and comparable efficacy, safety, and predictability at 3 months, but TG-LASIK offers faster postoperative visual recovery at 1 day and 1 week. TG-LASIK induces fewer HOAs than SMILE, but both procedures affect corneal biomechanics similarly.
BACKGROUND: ClincialTrials.gov identifier, NCT05611294.
摘要：
背景：这项研究的目的是比较地形图引导的激光辅助原位角膜磨镶术（TG-LASIK）和小切口微透镜摘除（SMILE®）矫正近视和近视散光的结果。
方法：在此前瞻性中，随机对侧研究，34例（68只眼）一只眼接受TG-LASIK，和微笑在他们的同伴的眼睛。功效,安全,可预测性,高阶像差，角膜断层扫描,生物力学,和患者报告的结局(PROs)在术前和术后3个月内进行评估.
结果：两个平台在3个月时显示出相当的疗效（TG-LASIK1.08±0.19；SMILE0.98±0.17，p=0.055）。然而,TG-LASIK显示更快的视觉恢复，63%和89%的人在1天和1周时达到20/16或更好的非矫正视力（UDVA），分别,与微笑相比（34%和63%；p<0.05）。在3个月时，TG-LASIK和SMILE之间的安全性指数没有显着差异（p=0.223）。TG-LASIK和SMILE有44％和56％的眼睛在0.13D内的球形等效（SEQ）目标，分别。微笑引起更多的总高阶像差(HOAs)，垂直昏迷,斜三叶在3个月时优于TG-LASIK（p<0.05）。两个平台都显示出相似的上皮重塑增加，但是在7.0毫米的鼻带区域，SMILE诱导的上皮比TG-LASIK厚。3个月时角膜滞后(CH)和角膜阻力因子(CRF)差异无统计学意义(p>0.05)。报告的眩光症状，光环,戒指,星爆,或干眼症在3个月时组间无显著差异(p>0.05).总的来说,59%的患者在1个月时更喜欢使用TG-LASIK治疗的眼睛，但65%的患者在3个月时没有特定的眼睛偏好。
结论：TG-LASIK和SMILE显示出优异且相当的疗效，安全,3个月时的可预测性，但TG-LASIK在术后1天和1周时提供更快的视力恢复。TG-LASIK诱导的HOAs少于微笑，但这两种手术对角膜生物力学的影响相似。
背景：ClincialTrials.gov标识符，NCT05611294。
方法：在此前瞻性中，随机对侧研究，34例（68只眼）一只眼接受TG-LASIK，和微笑在他们的同伴的眼睛。功效,安全,可预测性,高阶像差，角膜断层扫描,生物力学,和患者报告的结局(PROs)在术前和术后3个月内进行评估.
结果：两个平台在3个月时显示出相当的疗效（TG-LASIK1.08±0.19；SMILE0.98±0.17，p=0.055）。然而,TG-LASIK显示更快的视觉恢复，63%和89%的人在1天和1周时达到20/16或更好的非矫正视力（UDVA），分别,与微笑相比（34%和63%；p<0.05）。在3个月时，TG-LASIK和SMILE之间的安全性指数没有显着差异（p=0.223）。TG-LASIK和SMILE有44％和56％的眼睛在0.13D内的球形等效（SEQ）目标，分别。微笑引起更多的总高阶像差(HOAs)，垂直昏迷,斜三叶在3个月时优于TG-LASIK（p<0.05）。两个平台都显示出相似的上皮重塑增加，但是在7.0毫米的鼻带区域，SMILE诱导的上皮比TG-LASIK厚。3个月时角膜滞后(CH)和角膜阻力因子(CRF)差异无统计学意义(p>0.05)。报告的眩光症状，光环,戒指,星爆,或干眼症在3个月时组间无显著差异(p>0.05).总的来说,59%的患者在1个月时更喜欢使用TG-LASIK治疗的眼睛，但65%的患者在3个月时没有特定的眼睛偏好。
结论：TG-LASIK和SMILE显示出优异且相当的疗效，安全,3个月时的可预测性，但TG-LASIK在术后1天和1周时提供更快的视力恢复。TG-LASIK诱导的HOAs少于微笑，但这两种手术对角膜生物力学的影响相似。
背景：ClincialTrials.gov标识符，NCT05611294。
