Linking Optic Nerve Lesion Length at MRI and the Retinal Axonal Loss at 12 Months From a Clinical Episode of Optic Neuritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Severity of retinal axonal loss around papilla after a clinical episode of optic neuritis
研究概览
简要总结
This study evaluates the length of optic nerve lesion on 3D-DIR sequence as an imaging biomarker predictive of retinal axonal loss and visual disability, 12 months after the occurence of a first clinical episode of optic neuritis.
详细描述
Neurologists and Neuro-Ophthalmologists are in need for reliable and robust imaging biomarkers enabling to predict retinal axonal loss and visual disability after clinical episode of optic neuritis (ON). Length of optic nerve lesion measured on MRI may be one of them.
The aim of our study is to measure the association between the extent of inflammatory demyelinating process on optic nerve at the acute of ON and the retinal degenerative process following optic nerve injury.
The investigators planned to include 50 patients suffering from a recent clinical episode of ON.
Extent of demyelinating inflammatory process will be assessed by the length of optic nerve double inversion recovery (DIR) hypersignal at the acute phase of ON.
The axonal degenerative process following optic nerve demyelinating injury will be assessed by retinal atrophy measured on optical coherence tomography at 12 months after ON, by visual disability measured on low vision contrast acuity scale and by microstructural quality analysis of optic nerve measured on diffusion tensor imaging sequence of the optic nerve.
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
- •patient suffering from an acute clinical episode of optic neuritis (ON) confirmed by neurophthalmological examination
- •< 2 months between start of acute episode of ON and inclusion
排除标准
- •past history of homolateral episode of ON
- •retinal diseases
- •diabeta mellitus
- •pregnancy
结局指标
主要结局
Severity of retinal axonal loss around papilla after a clinical episode of optic neuritis
时间窗: 12 months
peripapillary RNFL thickness decrease
次要结局
- Severity of retinal axonal loss within macula after a clinical episode of optic neuritis(12 months)
- Severity of visual disability after a clinical episode of optic neuritis(12 months)
- Severity of microstructural architecture of optic nerve after a clinical episode of optic neuritis(12 months)
- Progression of optic nerve lesion length(12 months)