跳至主要内容
临床试验/NCT04448613
NCT04448613已完成不适用

Precise High Resolution MRI to Increase Accuracy and Gain Confidence to Diagnose Patients With Optic Disc Edema

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2020年6月17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
197
试验地点
1
主要终点
FLAIR hypersignal size: larger diameters and area

研究概览

简要总结

The presence of optic disc swelling at the fundus is a non-specific clinical sign that can occur in many ophthalmologic, neuro-ophthalmologic or encephalic pathologies. The diagnostic range is vast, including inflammatory pathologies of the optic nerve, infiltrative or compressive orbital pathologies, idiopathic or secondary intracranial hypertensions, not to mention the pseudo optic disc swelling found in drüsens.

MRI is increasingly being used as a first-line examination to obtain an etiologic diagnosis in a patient with optic disc swelling. It allows a rapid diagnosis to be made in cases of inflammatory pathology or compressive or infiltrative pathology. It can provide very suggestive elements in the case of intracranial hypertension. It appears to be potentially useful in diagnosing ischemic optic neuropathy or in directing towards an etiological diagnosis of Giant Cell Arteritis.

The development of new high-resolution MRI sequences has made it possible to obtain extremely fine resolutions of a few hundred microns in the plane. Apart from a few clinical cases and small series, there is no precise evaluation of the interest of these new sequences in the positive and etiological diagnosis of ophthalmological, neuro-ophthalmological and encephalic pathologies responsible for the presence of optic disc swelling.

The objective of our study is therefore to evaluate the diagnostic contribution and the gain in diagnostic confidence provided by these new sequences in the context of pathologies manifesting as optic disc swelling.

研究设计

研究类型
Observational
观察模型
Case Only
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
否

入选标准

  • •Patient over 18 years old
  • •presenting a papillary edema detected clinically at the back of the eye
  • •Express consent to participate in the study
  • •Affiliate or beneficiary of a Social Security scheme

排除标准

  • •MRI contraindication (electrical device, metallic foreign body, claustrophobia)
  • •Patient benefiting from a legal protection measure
  • •Pregnant or breastfeeding woman

结局指标

主要结局

FLAIR hypersignal size: larger diameters and area

时间窗: baseline

larger diameters and area of FLAIR hypersignal

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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