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临床试验/NCT02573792
NCT02573792已完成不适用

Optical Coherence Tomography for the Etiological Diagnosis of Inflammatory Optic Neuritis

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年10月5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
120
试验地点
1
主要终点
Sensitivity of the OCT, expressed as a percentage, for the etiological diagnosis of optical neuritis

研究概览

简要总结

Optic neuritis (ON) can remain isolated or reveal a widespread and chronic disease of the central nervous system (CNS), a multiple sclerosis (MS) or, more rarely, a Devic's neuromyelitis optica (NMO) or a systemic disease.

The optical coherence tomography (OCT) is a retinal imaging technique to measure the thickness of the retina and its different layers with an accuracy of 4-6 µM.

Costello et al have shown that approximately 75% of 54 MS patients have developed within 3 to 6 months after a ON a loss of 10 to 40 µM in the thickness of the peripapillary retinal nerve fiber layer (RNFL).

The etiologic diagnosis of ON has been transformed in recent years. MS can now be diagnosed by McDonald's MRI criteria and NMO by the AQP4 antibodies (anti-aquaporin- 4) antibodies and the anti-MOG (myelin-oligodendrocyte glycoprotein) antibodies.

The diagnosis and prognosis value of the OCT in patients with ON is not well known

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • first onset of an optical neuritis lasting for less than 3 months

排除标准

  • Contra-indication to MRI
  • Patient opposed to participation in the study
  • Pregnant or lactating woman
  • Patient under a measure of legal protection
  • Absence of affiliation to social security or universal health coverage (CMU)

结局指标

主要结局

Sensitivity of the OCT, expressed as a percentage, for the etiological diagnosis of optical neuritis

时间窗: One year

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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