NCT04153773已完成不适用
Retinal Thickness as a Potential Biomarker of Neurodegeneration and Early Cognitive Impairment in Patients With Multiple Sclerosis
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
- 否
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
Ahmed Esmael
Assistant Prof of Neurology
Mansoura University Hospital
研究点 (1)
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