跳至主要内容
临床试验/NCT06650306
NCT06650306招募中不适用

The Impact of Soft Contact Lenses on the Corneal Neuromediators and Optical Quality in High Myopia Prior to SMILE

yuhao shao1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Corneal stromal lenticule Neuromediators

研究概览

简要总结

To investigate the influence of Neuromediators expression in corneal stromal lenticules and corneal injury repair after small incision extraction

详细描述

This study included 160 eyes from high myopia patients who underwent Small Incision Lenticule Extraction. Patients were devided into three groups based on duration of wearing SCLs: > 10 years group, ≤ 10 years group, and NW group (not SCLs). Corneal higher-order aberrations and densitometry were evaluated using a Pentacam system. Neuromediator levels in corneal stromal lenticules were analyzed using ELISA and immunofluorescence

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥ 18 years with stable refraction for at least two years;
  • spherical equivalent (SE) < -6.00 D;
  • corrected distance visual acuity of 20/20 or better;
  • no history of using rigid gas permeable lenses or orthokeratology (OK) lenses prior to examination

排除标准

  • a history of moderate to severe dry eye as well as any ocular or systemic disease that would contraindicate laser refractive surgery.

结局指标

主要结局

Corneal stromal lenticule Neuromediators

时间窗: baseline

Corneal neuromediators, including NGF(pg/mL), CGRP(pg/mL), SP(pg/mL), IGFBP-1(ng/mL), and MANF(pg/mL), which play pivotal roles in maintaining normal physiological functions of the cornea.

次要结局

  • Corneal Aberration(baseline)
  • Corneal Densitometry(baseline)

研究者

发起方
yuhao shao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

yuhao shao

MD

Tongji University

研究点 (1)

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