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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Recruiting

CT.gov ID

NCT04448613

Collaborator

(none)

250

Enrollment

Location

35.4

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Optic Disk Magnetic Resonance Imaging	Other: MRI

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 17, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Outcome Measures

Primary Outcome Measures

FLAIR hypersignal size: larger diameters and area [baseline]
larger diameters and area of FLAIR hypersignal

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation Ophtalmologique Adolphe de Rothschild (FOR)	Paris		France	75019

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT04448613

Other Study ID Numbers:

2020-A00502-37

First Posted:

Jun 26, 2020

Last Update Posted:

Apr 7, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Papilledema

Study Results

No Results Posted as of Apr 7, 2022