Randomized controlled trial on corneal denervation, neuroinflammation and ocular surface in corneal lenticule extraction for advanced refractive correction (CLEAR) and small incision lenticule extraction (SMILE).

IF 4.1 1区 医学 Q1 OPHTHALMOLOGY
Mingyi Yu, Chang Liu, Isabelle Xin Yu Lee, Victor Wei-Tse Hsu, Regina Kay Ting Wong, Ansa Anam, Rong Lim, Jodhbir S Mehta, Yu-Chi Liu
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Abstract

Background: To investigate and compare the corneal denervation, tear neuromediators, and ocular surface changes following corneal lenticule extraction for advanced refractive correction (CLEAR) versus small incision lenticule extraction (SMILE).

Methods: In this randomized clinical trial, 19 patients were randomized to undergo CLEAR in one eye and SMILE in the other eye. Ocular surface assessments, in vivo confocal microscopy for seven corneal nerve parameters, four corneal dendritic cell parameters, three corneal epithelial parameters, and tear neuromediator analysis were performed preoperatively and 1, 3, 6 and 12 months postoperatively.

Results: There were no significant differences in all ocular surface assessments between CLEAR and SMILE throughout postoperative 1 year. CLEAR and SMILE led to significant and comparable reductions of corneal nerve fiber density (CNFD), nerve branch density, total branch density, nerve fiber length, area, and fiber fractal dimension, which did not restore even at 1 year. The reduction in CNFD was significantly correlated with the corrected spherical equivalent in both surgical types. Although post-SMILE eyes had significantly higher nerve growth factor concentrations at 1 month, there was no significant difference in substance P and calcitonin gene-related peptide (CGRP) concentrations between SMILE and CLEAR.

Conclusions: CLEAR and SMILE had comparable effects on ocular surface, corneal denervation and postoperative neuroinflammation. Corneal nerve metrics did not restore even at 1 year for both procedures.

Trial registration number: ClinicalTrials.gov NCT06774651, registration on 14 January 2025, https://clinicaltrials.gov/study/NCT06774651 .

高级屈光矫正(CLEAR)和小切口角膜晶状体摘除术(SMILE)中角膜去神经支配、神经炎症和眼表的随机对照试验。
背景:研究和比较先进屈光矫正(CLEAR)和小切口晶状体摘除(SMILE)后角膜去神经控制、撕裂神经介质和眼表的变化。方法:在本随机临床试验中,19例患者随机接受一只眼CLEAR和另一只眼SMILE。术前、术后1、3、6、12个月分别进行眼表评估、角膜7个神经参数、4个角膜树突状细胞参数、3个角膜上皮参数的体内共聚焦显微镜检查和泪液神经介质分析。结果:术后1年内,CLEAR和SMILE的所有眼表评估均无显著差异。CLEAR和SMILE可显著降低角膜神经纤维密度(CNFD)、神经分支密度、总分支密度、神经纤维长度、面积和纤维分形维数,即使在1年后也没有恢复。在两种手术类型中,CNFD的减少与校正的球形当量显著相关。尽管术后1个月时,SMILE组的神经生长因子浓度明显升高,但在P物质和降钙素基因相关肽(CGRP)浓度方面,SMILE组与CLEAR组无显著差异。结论:CLEAR和SMILE在眼表、角膜去神经支配和术后神经炎症方面具有相当的效果。两种手术的角膜神经指标在1年后也没有恢复。试验注册号:ClinicalTrials.gov NCT06774651,注册日期为2025年1月14日,网址:https://clinicaltrials.gov/study/NCT06774651。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Eye and Vision
Eye and Vision OPHTHALMOLOGY-
CiteScore
8.60
自引率
2.40%
发文量
89
审稿时长
15 weeks
期刊介绍: Eye and Vision is an open access, peer-reviewed journal for ophthalmologists and visual science specialists. It welcomes research articles, reviews, methodologies, commentaries, case reports, perspectives and short reports encompassing all aspects of eye and vision. Topics of interest include but are not limited to: current developments of theoretical, experimental and clinical investigations in ophthalmology, optometry and vision science which focus on novel and high-impact findings on central issues pertaining to biology, pathophysiology and etiology of eye diseases as well as advances in diagnostic techniques, surgical treatment, instrument updates, the latest drug findings, results of clinical trials and research findings. It aims to provide ophthalmologists and visual science specialists with the latest developments in theoretical, experimental and clinical investigations in eye and vision.
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