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NCT Number: NCT07837050

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

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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Key information

Conditions

Demyelinating Diseases Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pupillometry measures

Diagnostic Test

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

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)

    Time frame: Baseline

    Pupil diameter at myosis measured with a portable pupillometer.

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)

    Time frame: Baseline

    Pupil diameter at mydriasis measured with a portable pupillometer.

  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).

    Time frame: Baseline

    QPi (Quantitative Pupillary Light Reflex) score (scale from 0 to 5) measured with a portable pupillometer.

  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)

    Time frame: Baseline

    Anisocories (in mm) quantified with a portable pupillometer.

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

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at myosis and the visual acuity score.

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

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at myosis and the low contrast visual acuity score.

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

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at myosis and the presence of color vision abnormalies.

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

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at myosis and the OCT-measured RNFL thickness.

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

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at myosis and the the OCT-measured GCIPL thickness.

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

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at myosis and the VEP-measured P100 wave latency.

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

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at myosis and VEP amplitudes.

  11. Comparison of the frequencies of optic nerve impairments depending on the final diagnosis.

    Time frame: Once the final diagnosis is known.

    Frequency of optic nerve impairments among patients with an identical final diagnosis (multiple sclerosis and its different clinical forms, other inflammatory disorder of the CNS, non inflammatory disorder of the nervous system, no nervous system disorder).

  12. Correlation between pupillometry-measured pupil diameter at mydriasis with traditional visual acuity

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at mydriasis and the visual acuity score.

  13. Correlation between pupillometry-measured QPi score with traditional visual acuity

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured QPi score and the visual acuity score.

  14. Correlation between pupillometry-measured anisocory with traditional visual acuity

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured anisocory and the visual acuity score.

  15. Correlation between pupillometry-measured pupil diameter at mydriasis and low contrast visual acuity

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at mydriasis and the low contrast visual acuity score.

  16. Correlation between pupillometry-measured QPi score and low contrast visual acuity

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured QPi score and the low contrast visual acuity score.

  17. Correlation between pupillometry-measured anisocory and low contrast visual acuity

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured anisocory and the low contrast visual acuity score.

  18. Correlation between pupillometry-measured pupil diameter at mydriasis and the existence or not of color vision abnormalities

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at mydriasis and the presence of color vision abnormalies.

  19. Correlation between pupillometry-measured QPi score and the existence or not of color vision abnormalities

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured QPi score and the presence of color vision abnormalies.

  20. Correlation between pupillometry-measured anisocory and the existence or not of color vision abnormalities

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured anisocory and the presence of color vision abnormalies.

  21. Correlation between pupillometry-measured pupil diameter at mydriasis and the Retinal Nerve Fiber Layer (RNFL) thickness

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at mydriasis and the OCT-measured RNFL thickness.

  22. Correlation between pupillometry-measured QPi score and the Retinal Nerve Fiber Layer (RNFL) thickness

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured QPi and the OCT-measured RNFL thickness.

  23. Correlation between pupillometry-measured anisocory and the Retinal Nerve Fiber Layer (RNFL) thickness

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured anisocory and the OCT-measured RNFL thickness.

  24. Correlation between pupillometry-measured pupil diameter at mydriasis and the Ganglion Cell - Inner Plexiform Layer (GCIPL) thickness

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at mydriasis and the the OCT-measured GCIPL thickness.

  25. Correlation between pupillometry-measured QPi score and the Ganglion Cell - Inner Plexiform Layer (GCIPL) thickness

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured QPi score and the the OCT-measured GCIPL thickness.

  26. Correlation between pupillometry-measured anisocory and the Ganglion Cell - Inner Plexiform Layer (GCIPL) thickness

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured anisocory and the the OCT-measured GCIPL thickness.

  27. Correlation between pupillometry-measured pupil diameter at mydriasis and the P100 wave latency

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at mydriasis and the VEP-measured P100 wave latency.

  28. Correlation between pupillometry-measured QPi score and the P100 wave latency

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured QPi score and the VEP-measured P100 wave latency.

  29. Correlation between pupillometry-measured anisocory and the P100 wave latency

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured anisocory and the VEP-measured P100 wave latency.

  30. Correlation between pupillometry-measured pupil diameter at mydriasis and VEP amplitudes.

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured pupil diameter at mydriasis and VEP amplitudes.

  31. Correlation between pupillometry-measured QPi score and VEP amplitudes.

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured QPi score and VEP amplitudes.

  32. Correlation between pupillometry-measured anisocory and VEP amplitudes.

    Time frame: Baseline

    Results of a parametric correlation test between pupillometry-measured anisocory and VEP amplitudes.

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: IRIS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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