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CompletedNCT03135574HYPER-IIIUpdated Jul 16, 2021

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

An observational study in Ophthalmoplegia, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-16.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
148
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ophthalmoplegia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Absolute contraindication to MRI or injection of contrast agents
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
148 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testMRI T2 sequence of the oculomotor tract

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

05

What researchers measure

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).

    Time frame: Baseline

06

Study locations

1 site
  • Fondation Ophtalmologique A. de Rothschild
    Paris, 75019, France
07

Registry details

Key details

Study ID
NCT03135574
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
May 1, 2017
Start date
Apr 16, 2017
Primary completion
Feb 22, 2021
Completion
Feb 22, 2021
Last update
Jul 16, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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