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

NCT03135574 | Completed

• 1 other identifier: FHN_2016_27
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ophthalmoplegia

Outcome Measures

Primary Outcomes (1)

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

  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).

  Baseline

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients (18 years of age or older) benefiting from an MRI, requested by the ophthalmologist for an assessment of an ophthalmoplegia.

You may qualify if:

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

You may not qualify if:

• Absolute contraindication to MRI or injection of contrast agents

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Ophthalmoplegia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 1, 2017
• Study Start: April 16, 2017
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

FR (1)