Skip to main content
OpenTrials
Completed

NCT Number: NCT04448613

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique Adolphe de Rothschild (FOR)

Paris, 75019, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

Patients with optic disc swelling diagnosed by a fundus and included in the study will have a brain MRI and visual pathways lasting 30 minutes.

Two additional 10-minute sequences will be added to the standard protocol.

Primary outcomes

  1. FLAIR hypersignal size: larger diameters and area

    Time frame: baseline

    larger diameters and area of FLAIR hypersignal

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: PAGODE

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2020
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.