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Not yet recruitingNCT07837050IRISUpdated Sep 23, 2026

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

An interventional study of Pupillometry measures in Demyelinating Diseases, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Primary conditionMultiple SclerosisRegistry: Demyelinating DiseasesReclassifiedWhy we changed it
Registry
Demyelinating Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Multiple Sclerosis
Why
  1. The study's title name Multiple Sclerosis, a narrower term within Demyelinating Diseases.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Demyelinating Diseases

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Keywords

  • multiple sclerosis
  • optic nerve impairment
  • pupillometer
03

In context

Multiple Sclerosis Reclassified

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.

Browse Centre Hospitalier Universitaire de Nice studies →

Compared within Multiple Sclerosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Demyelinating Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Neurological or ophtamological history that could interfere with the interpretation of neuro-ophtalmological tests.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Patients with Suspicion of Demyelinating Diseases

    Diagnostic Test: Pupillometry measures

Interventions

  • Diagnostic testPupillometry measures

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

06

What researchers measure

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

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

    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).

    Time frame: Once the final diagnosis is known.

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 12 months is below that.

Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2026
First posted
Sep 23, 2026
StartEst.
Sep 24, 2026
Primary completionEst.
Sep 24, 2027
CompletionEst.
Sep 24, 2027
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07837050
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Sep 23, 2026
Start date
Sep 24, 2026 (estimated)
Primary completion
Sep 24, 2027 (estimated)
Completion
Sep 24, 2027 (estimated)
Last update
Sep 23, 2026

Study contacts

Mikael Cohen, MD-PhD
Contact
cohen.m@chu-nice.fr
+33 04 92 03 82 52
Cassandre Landes-Château, PhD
Contact
chateau.c@chu-nice.fr
+33 04 92 03 41 26

Oversight

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

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