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

Completed

• Conditions: Ophthalmoplegia

• Registration Number: NCT03135574
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-16
• Study First Submitted: 2017-04-25
• Study First Submitted QC: 2017-04-28
• Study First Posted: 2017-05-01
• Primary Completion: 2021-02-22
• Study Completion: 2021-02-22
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fondation Ophtalmologique A. de Rothschild; 🇫🇷 Paris, France