Prevalence of a High-intensity Signal of the Oculomotor Nerve on T2 MRI Sequence in Patients With Ophthalmoplegia

Oculomotor nerve (third cranial nerve or III) palsy is a relatively frequent cause of consultation in ophthalmology.

It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the oculomotor tract is the first-line examination required. In the usual clinical practice, the investigators noticed in several patients unusual areas of high-intensity signal within the oculomotor nerve on T2 sequence, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment). This abnormal signal, at the best knowledge of the investigators, has never been reported in the literature and could confirm the nerve impairment.

In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this new MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis (inflammatory or ischemic origin). A T2 sequence focused on the III could thus be systematically included in the usual MRI protocol.

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Key information

Conditions

Ophthalmoplegia Cranial Nerve Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Ocular Motility Disorders Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Ophthalmoplegia whatever the clinical form (unilateral or not, isolated or not, sudden or progressive onset)

Exclusion criteria

Absolute contraindication to MRI or injection of contrast agents

Treatment and study plan

MRI T2 sequence of the oculomotor tract

Diagnostic Test

Patients with ophthalmoplegia will benefit from an MRI T2 sequence of the oculomotor tract (additional time of 4 minutes).

Primary outcomes

High-intensity signal of the oculomotor nerve on MRI T2 sequence (presence or absence, determined by a radiologist)

Time frame: Baseline

High-intensity signal within the oculomotor nerve on T2 sequence, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment).

High-intensity signal on T2 MRI sequence is defined as a signal area which is more intense than the contralateral nerve or more intense than the white matter signal.

A double separate reading of the imaging will be carried out by an experienced radiologist and a junior radiologist on anonymized MRIs, with no access to clinical elements and interpretation of the other radiologist. In case of discrepancy between the radiologists, the final decision will be made by a third experienced radiologist under the same conditions (no access to clinical data, no access to the other evaluations).

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: HYPER-III

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: May 1, 2017
Registry last updated: Jul 16, 2021

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.

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