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临床试验/NCT04153773
NCT04153773已完成不适用

Retinal Thickness as a Potential Biomarker of Neurodegeneration and Early Cognitive Impairment in Patients With Multiple Sclerosis

Mansoura University Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Optical coherence tomography

研究概览

简要总结

The aim of this study is to investigate the relationship between cognitive impairment and retinal nerve fiber layer & ganglion cell inner plexiform layer in MS.

详细描述

Cross-sectional study design, including 60 patients and 30 healthy controls. Subjects were investigated clinically, underwent retinal optical coherence tomography (OCT) and comprehensive cognitive assessments. The correlation between these modalities was evaluated by Spearman correlation.

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
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 60 MS patients diagnosed according to the revised McDonald criteria 2010 were included
  • 30 healthy subjects with age and sex match control group.

排除标准

  • Medical disorder other than MS that may grossly affect cognitive functions
  • Pregnancy,
  • Previous neurological or neuropsychiatric disorders,
  • Alcohol or drug abuse,
  • MRI findings which could not be attributed to MS.
  • Severe visual disorders (> ± 6.0 dpt.)
  • History of ocular surgery, glaucoma or diabetes.

结局指标

主要结局

Optical coherence tomography

时间窗: 24-48 hours

OCT imaging was performed by spectral domain-optical coherence tomography to assess the retinal thickness.

次要结局

  • Cognitive assessment(24-48 hours)
  • Expanded Disability Status Scale (EDSS)(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Esmael

Assistant Prof of Neurology

Mansoura University Hospital

研究点 (1)

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