NCT01272596已完成不适用
Evaluation of Low Contrast Sloan Visual Charts as Method for the Assessment of Disease Progression in Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Contrast Acuity
研究概览
简要总结
Impairment of visual deficits, in particular contrast acuity and contrast impairment are frequent symptoms in MS. However, visual function is not appropriately covered by the standard tools for clinical assessment, namely, the EDSS and the MSFC.
The primary aim of this study is to investigate, whether in MS patients contrast acuity and sensitivity change over a period of two years.
Secondary aims are the correlation of visual contrast parameters with structural retinal changes and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically Isolated Syndrome or definite MS (relapsing-remitting or secondary progressive course)
- •Written Informed Consent
排除标准
- •Relapse within the last 30 Days
- •Significant Cognitive Impairment
- •Severely Decreased Visual Acuity
- •Preexisting Severe Retinal Pathology
结局指标
主要结局
Visual Contrast Acuity
时间窗: 24 Months
次要结局
- Structural and Functional Changes of Optic Pathway(24 Months)
- Clinical Neurological Assessment(24 Months)
- Contrast Sensitivity(24 Months)
- Quality of Life(24 Months)
研究者
Jan-Markus Dörr
PI
Charite University, Berlin, Germany
研究点 (1)
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