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

Recruiting

• Conditions: Optic Disk; Magnetic Resonance Imaging

• Registration Number: NCT04448613
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-17
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-26
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-11
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FLAIR hypersignal size: larger diameters and area	baseline	larger diameters and area of FLAIR hypersignal

Trial Locations

Locations (1)

Fondation Ophtalmologique Adolphe de Rothschild (FOR); 🇫🇷 Paris, France