Use of a Portable Pupillometer to Detect Optic Nerve Impairment in Patients With Suspected Multiple Sclerosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCentre Hospitalier Universitaire de Nice

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Pupillometry measures

    Diagnostic test

    Pupillometry measurements will be carried out using a portable pupillometer for each eye.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients with Suspicion of Demyelinating DiseasesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline
4

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.

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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