Demyelinating DiseasesIRISNCT07837050
Use of a Portable Pupillometer to Detect Optic Nerve Impairment in Patients With Suspected Multiple Sclerosis
A study testing Pupillometry measures in people with Demyelinating Diseases, run by Centre Hospitalier Universitaire de Nice.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Demyelinating Diseases
- What is being tested?
- Pupillometry measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 24 Sep 2026to 24 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Neurological or ophtamological history that could interfere with the interpretation of neuro-ophtalmological tests.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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).
- Conditions
- Demyelinating Diseases
- Being tested
- Pupillometry measures
- Keywords
- multiple sclerosis, optic nerve impairment, pupillometer
- Medical subject headings
- Demyelinating Diseases, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupillometry measuresDiagnostic test
Pupillometry measurements will be carried out using a portable pupillometer for each eye.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Suspicion of Demyelinating Diseases | Experimental | Not described Receives: Diagnostic Test: Pupillometry measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (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)
Pupil diameter at mydriasis measured with a portable pupillometer.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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).
Measured: Once the final diagnosis is known.
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.
Measured: Baseline
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.
Measured: Baseline
Correlation between pupillometry-measured anisocory with traditional visual acuity
Results of a parametric correlation test between pupillometry-measured anisocory and the visual acuity score.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Correlation between pupillometry-measured QPi score and VEP amplitudes.
Results of a parametric correlation test between pupillometry-measured QPi score and VEP amplitudes.
Measured: Baseline
Correlation between pupillometry-measured anisocory and VEP amplitudes.
Results of a parametric correlation test between pupillometry-measured anisocory and VEP amplitudes.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start24 Sep 2026 (estimated)
- Primary completion24 Sep 2027 (estimated)
- Study completion24 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demyelinating DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837050
- Sponsor's protocol ID
- 26-PP-07
- Acronym
- IRIS
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Portable Pupillometer to Detect Optic Nerve Impairment in Patients With Suspected Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07837050
- Acronym / sponsor ID
- IRIS / 26-PP-07
- Conditions
- Demyelinating Diseases
- Keywords
- multiple sclerosis, optic nerve impairment, pupillometer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 24 Sep 2026 (estimated)
- Primary completion
- 24 Sep 2027 (estimated)
- Study completion
- 24 Sep 2027 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Suspicion of Demyelinating Diseases | Experimental | Diagnostic Test: Pupillometry measures |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Neurological or ophtamological history that could interfere with the interpretation of neuro-ophtalmological tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pupillometry measuresPupillometry measurements will be carried out using a portable pupillometer for each eye. | Diagnostic test | Patients with Suspicion of Demyelinating Diseases |
Primary outcome
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.
32 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)
Time frame: Baseline
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
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
Correlation between pupillometry-measured pupil diameter at myosis and traditional visual acuity
Time frame: Baseline
Correlation between pupillometry-measured pupil diameter at myosis and low contrast visual acuity
Time frame: Baseline
Correlation between pupillometry-measured pupil diameter at myosis and the existence or not of color vision abnormalities
Time frame: Baseline
Correlation between pupillometry-measured pupil diameter at myosis and the Retinal Nerve Fiber Layer (RNFL) thickness
Time frame: Baseline
Correlation between pupillometry-measured pupil diameter at myosis and the Ganglion Cell - Inner Plexiform Layer (GCIPL) thickness
Time frame: Baseline
Correlation between pupillometry-measured pupil diameter at myosis and the P100 wave latency
Time frame: Baseline
Correlation between pupillometry-measured pupil diameter at myosis and VEP amplitudes.
Time frame: Baseline
Comparison of the frequencies of optic nerve impairments depending on the final diagnosis.
Time frame: Once the final diagnosis is known.
Correlation between pupillometry-measured pupil diameter at mydriasis with traditional visual acuity
Time frame: Baseline
Correlation between pupillometry-measured QPi score with traditional visual acuity
Time frame: Baseline
Correlation between pupillometry-measured anisocory with traditional visual acuity
Time frame: Baseline
Correlation between pupillometry-measured pupil diameter at mydriasis and low contrast visual acuity
Time frame: Baseline
Correlation between pupillometry-measured QPi score and low contrast visual acuity
Time frame: Baseline
Correlation between pupillometry-measured anisocory and low contrast visual acuity
Time frame: Baseline
Correlation between pupillometry-measured pupil diameter at mydriasis and the existence or not of color vision abnormalities
Time frame: Baseline
Correlation between pupillometry-measured QPi score and the existence or not of color vision abnormalities
Time frame: Baseline
Correlation between pupillometry-measured anisocory and the existence or not of color vision abnormalities
Time frame: Baseline
Correlation between pupillometry-measured pupil diameter at mydriasis and the Retinal Nerve Fiber Layer (RNFL) thickness
Time frame: Baseline
Correlation between pupillometry-measured QPi score and the Retinal Nerve Fiber Layer (RNFL) thickness
Time frame: Baseline
Correlation between pupillometry-measured anisocory and the Retinal Nerve Fiber Layer (RNFL) thickness
Time frame: Baseline
Correlation between pupillometry-measured pupil diameter at mydriasis and the Ganglion Cell - Inner Plexiform Layer (GCIPL) thickness
Time frame: Baseline
Correlation between pupillometry-measured QPi score and the Ganglion Cell - Inner Plexiform Layer (GCIPL) thickness
Time frame: Baseline
Correlation between pupillometry-measured anisocory and the Ganglion Cell - Inner Plexiform Layer (GCIPL) thickness
Time frame: Baseline
Correlation between pupillometry-measured pupil diameter at mydriasis and the P100 wave latency
Time frame: Baseline
Correlation between pupillometry-measured QPi score and the P100 wave latency
Time frame: Baseline
Correlation between pupillometry-measured anisocory and the P100 wave latency
Time frame: Baseline
Correlation between pupillometry-measured pupil diameter at mydriasis and VEP amplitudes.
Time frame: Baseline
Correlation between pupillometry-measured QPi score and VEP amplitudes.
Time frame: Baseline
Correlation between pupillometry-measured anisocory and VEP amplitudes.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Pupillometry measures in people with Demyelinating Diseases, run by Centre Hospitalier Universitaire de Nice.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikael Cohen, MD-PhD (+33 04 92 03 82 52, cohen.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.