地形图引导的准分子激光原位角膜磨镶术与角膜屈光透镜切除术（KLEx）的三个月综合结果：一项前瞻性对侧研究。

Three-Month Comprehensive Outcomes of Topography-Guided LASIK Versus Keratorefractive Lenticule Extraction (KLEx): A Prospective Contralateral Study.

作者信息

Moin Kayvon A, Manion Garrett N, Pandiri Srujay, Hoopes Phillip C, Moshirfar Majid

机构信息

Hoopes Vision Research Center, Hoopes Vision, 11820 S State St #200, Draper, UT, 84020, USA.

Creighton University School of Medicine, Omaha, NE, USA.

出版信息

Ophthalmol Ther. 2024 Aug;13(8):2265-2284. doi: 10.1007/s40123-024-00987-y. Epub 2024 Jul 1.

DOI:10.1007/s40123-024-00987-y

PMID:38951314

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11246376/

Abstract

INTRODUCTION

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.

CONCLUSION

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.

TRIAL REGISTRATION

ClincialTrials.gov identifier, NCT05611294.

摘要

引言

本研究旨在比较地形图引导的准分子原位角膜磨镶术（TG-LASIK）和小切口基质透镜切除术（SMILE®）矫正近视和近视散光的效果。

方法

在这项前瞻性、随机对照对侧眼研究中，34例患者（68只眼）一只眼接受TG-LASIK手术，另一只眼接受SMILE手术。在术前及术后3个月内评估疗效、安全性、可预测性、高阶像差、角膜地形图、生物力学以及患者报告的结局（PROs）。

结果

两种手术平台在术后3个月时显示出相当的疗效（TG-LASIK 1.08±0.19；SMILE 0.98±0.17，p = 0.055）。然而，TG-LASIK显示出更快的视力恢复，与SMILE相比，分别有63%和89%的患者在术后1天和1周时未矫正远视力（UDVA）达到20/16或更好（SMILE为34%和63%；p<0.05）。TG-LASIK和SMILE在术后3个月时的安全指数无显著差异（p = 0.223）。TG-LASIK和SMILE分别有44%和56%的眼的等效球镜度（SEQ）在目标值的0.13D范围内。术后3个月时，SMILE比TG-LASIK诱导产生更多的总高阶像差（HOAs）、垂直彗差和斜三叶像差（p<0.05）。两种手术平台在上皮重塑方面均有相似程度的增加，但在鼻侧7.0mm区域，SMILE诱导产生的上皮比TG-LASIK更厚。术后3个月时，角膜滞后（CH）或角膜阻力因子（CRF）无显著差异（p>0.05）。在术后3个月时，两组报告的眩光、光晕、光环、星芒或干眼症状无显著差异（p>0.05）。总体而言，59%的患者在术后1个月时更喜欢接受TG-LASIK手术的眼，但在术后3个月时，65%的患者没有特定的眼偏好。