Use of a Portable Pupillometer to Detect Optic Nerve Impairment in Pat

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

Not yet recruitingNot a drug-phase studyMS (type not specified)NCT07837050

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Pupillometry measures

What it measured

Main measures

  • 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)

    Baseline

    MRI lesionsMyelin repairRetina scans (OCT)

Other measures (32)

  • 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)

    Baseline

    MRI lesionsMyelin repairRetina scans (OCT)

  • 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).

    Baseline

    MRI lesionsMyelin repairRetina scans (OCT)

  • 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)

    Baseline

    MRI lesionsMyelin repairRetina scans (OCT)

  • Correlation between pupillometry-measured pupil diameter at myosis and traditional visual acuity

    Baseline

    Vision

  • Correlation between pupillometry-measured pupil diameter at myosis and low contrast visual acuity

    Baseline

    Vision

  • Correlation between pupillometry-measured pupil diameter at myosis and the existence or not of color vision abnormalities

    Baseline

    Vision

  • Correlation between pupillometry-measured pupil diameter at myosis and the Retinal Nerve Fiber Layer (RNFL) thickness

    Baseline

    Retina scans (OCT)

  • Correlation between pupillometry-measured pupil diameter at myosis and the Ganglion Cell - Inner Plexiform Layer (GCIPL) thickness

    Baseline

    Retina scans (OCT)

  • Correlation between pupillometry-measured pupil diameter at myosis and the P100 wave latency

    Baseline

    Myelin repair

  • Correlation between pupillometry-measured pupil diameter at myosis and VEP amplitudes.

    Baseline

    Myelin repair

Who could take part

MS (type not specified) · 18 to 60

Show the full criteria

Inclusion criteria

* 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 * Patients affiliated to a social security system * Patients who did not oppose to his participation in the clinical trial

Exclusion criteria

* Neurological or ophtamological history that could interfere with the interpretation of neuro-ophtalmological tests.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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).

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History

    1. Started

      Sept 2026

    2. Main results due

      Sept 2027

    3. Finished

      Sept 2027

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