An interventional study of • Neuro-Ophthalmological examination, Visual Acuity, Fundus, Visual Field, Color Vision, OCT, EDSS • NEI-VFQ 25 and the 10-item • VEPs, p-ERG and mf-ERG in Chronic Optic Neuropathy in Multiple Sclerosis, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science
Patients with multiple sclerosis (MS) may show chronic signs of optic neuropathy (CON) that may follow acute optic neuritis (secondary form of CON, S-CON) or occur independently of any acute demyelinating lesion of the optic nerve (primary form of CON, P-CON). In both S-CON and P-CON, a long term progressive ganglion cell axonal loss occurs. This axonal damage could be secondary to retrograde atrophy of axons within plaques of demyelination or a primary progressive degeneration of ganglion cells, but the underlying physiopathology has not been fully questioned in the different profile types of CON.
In this project, investigators aim at understanding the pathophysiology of S-CON and P-CON, i.e. secondary to demyelination or primary degeneration, in patients complaining of persistent visual complaints. In a first cross sectional study, 30 MS patients with mild to moderate P-CPON or S-CON and 30 age-matched control subjects will perform an extensive neuro-ophthalmological assessment including clinical examination, visual evoked potentials (pattern and low contrast), electroretinogram (pattern and multifocal ERG), OCT (peripapillary and macular volume scan segmentation protocols) and MRI of the optic nerve. In these patients with mild to moderate CON, investigators aim at differentiating patients showing predominant demyelination from those showing pure or predominant axonal degeneration. Visual function assessment and degree of axonal degeneration will be compared and correlated in the two types of underlying pathophysiology and in the group of control subject. In a following longitudinal study, the patients will be re-assessed a year later in order to evaluate the progression of CON in both profile types. Our hypothesis would be that visual function and progression is worse in the degeneration group as compared to the demyelination group. This study should help to find reliable measures of the pathophysiology of CON and correlate it with the long-term visual prognostic of the disease.
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This study's enrollment of 39 is below the median of 50 across 58 interventional studies indexed under Optic Neuritis.
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Inclusion Criteria:
Inclusion criteria for patients
For the diagnosis of optic neuropathy, patients will have to meet 3 of the 6 next criteria:
Disc pallor Diagnosis of mild to moderate optic neuropathy
Stable or worsening of visual acuity, visual field and/or RNFL in OCT, at 6 month of interval
- Inclusion criteria for controls
Exclusion Criteria:
Non inclusion criteria for patients.
Ophthalmological
Neurological
General
Non inclusion criteria for controls
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients with chronic optic neuropathy in multiple sclerosis
Procedure: • Neuro-Ophthalmological examination, Visual Acuity, Fundus, Visual Field, Color Vision, OCT, EDSS • NEI-VFQ 25 and the 10-item • VEPs, p-ERG and mf-ERG
healthy volunteers
Procedure: • Neuro-Ophthalmological examination, Visual Acuity, Fundus, Visual Field, Color Vision, OCT, EDSS • NEI-VFQ 25 and the 10-item • VEPs, p-ERG and mf-ERG
Change from Day0 15' P100 VEP latency at one year
15' VEP latency may be the best outcome that allow differentiating patients from controls, and each of the sub-group of patients
Time frame: D0 and one year
Change from Day0 100%, 2.5% and 1.25% ETDRS Visual Acuity at one year (composite measure)
Time frame: D0 and one year
Change from Day0 Visual field macular threshold and corrected mean visual field deficit at one year (composite measure)
Time frame: D0 and one year
change frome Day0 NEI-VFQ 25 composite score and 10-item score at one year (composite measure)
Time frame: D0 and one year
Change from Day0 N75, P100, N135 VEP latency and amplitude; P50, N95 ERG latency and amplitude; p1 mERG latency and amplitude at one year (composite measure)
Time frame: D0 and one year
Change from Day0 OCT peripapillary RNLF thickness and Ganglion cell layer average thickness on macular dense volume at one year (composite measure)
Time frame: D0 and one year
MRI presence or absence of optic nerve inflammatory signs on diameter of the optic nerve
Time frame: D0
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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