About this trial
In the diagnosis work-up of inflammatory disorders of the central nervous system (CNS), the assessment of optic nerve impairments, even in the absence of clinical symptoms, is now systematic, as it may shorten the time to diagnosis and facilitate early treatment initiation.
Currently, optic nerve impairments can be assessed using three paraclinical examinations, namely magnetic resonance imaging (MRI), visual evoked potentials (VEP) or optic coherence tomography (OCT). However, these investigations are complex and resource-intensive. The development of a simple, reliable and easily accessible clinical tool could therefore facilitate the detection of optic nerve impairments.
Unilateral or asymmetric optic nerve impairments, which are commonly observed in patients with inflammatory disorders of the CNS, translate into a reduction in efficiency of the pupillary light reflex, that can be detected by pupillometry. This technique consists in measuring pupil diameter and its variations and could represent a simple and convenient alternative to conventional investigations.
The aim of this study is therefore to compare the results obtained using a portable pupillometer in patients suspected of having an inflammatory disorder of the CNS, with and without optic nerve impairment as detected by conventional methods (MRI, VEP and OCT).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 - 60 years old
Patients sent to the CRC-SEP structure of the Nice hospital (CHU) with suspicion of a demyelinating disease
Patients who underwent brain MRI with dedicated orbital sequences
Patients who underwent a diagnostic work-up including VEP and OCT
Disqualifiers
Neurological or ophtamological history that could interfere with the interpretation of neuro-ophtalmological tests.
Trial design
Single group
Treatments tested in this trial
Pupillometry measures
Diagnostic testPupillometry measurements will be carried out using a portable pupillometer for each eye.
Treatment groups
Trial outcomes
Primary outcomes
Comparison of pupil diameter at myosis between patients suspected of having a demyelinating disease with an optic nerve impairment and those with no optic nerve impairment (as detected by MRI, VEP and OCT)
Pupil diameter at myosis measured with a portable pupillometer.
Secondary outcomes
Comparison of pupil diameter at mydriasis between patients suspected of having a demyelinating disease with an optic nerve impairment and those with no optic nerve impairment (as detected by MRI, VEP and OCT)
Pupil diameter at mydriasis measured with a portable pupillometer.
Comparison of pupillary reflex-generated constriction between patients suspected of having a demyelinating disease with an optic nerve impairment and those with no optic nerve impairment (as detected with MRI, VEP and OCT).
QPi (Quantitative Pupillary Light Reflex) score (scale from 0 to 5) measured with a portable pupillometer.
Comparison of anisocories between patients suspected of having a demyelinating disease with an optic nerve impairment and those with no optic nerve impairment (as detected with MRI, VEP and OCT)
Anisocories (in mm) quantified with a portable pupillometer.
Correlation between pupillometry-measured pupil diameter at myosis and traditional visual acuity
Results of a parametric correlation test between pupillometry-measured pupil diameter at myosis and the visual acuity score.
Locations
Sponsors and contacts
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