NCT03963310

Brief Summary

The visual prognosis of optic neuritis not related to multiple sclerosis is unknown, both in terms of functional recovery and evolution. This prospective cohort study aim to assess the ophthalmological evolution of patients presenting an episode of optic neuritis (NO) not related to a multiple sclerosis or to a clinically isolated syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2024

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

3.7 years

First QC Date

May 20, 2019

Last Update Submit

June 19, 2025

Conditions

Optic Neuritis

Outcome Measures

Primary Outcomes (3)

  • Visual acuity (ETDRS scale)

    Evolution over 1 year of the ophthalmological parameters of patients treated for an episode of optic neuritis not related to multiple sclerosis or a clinically isolated syndrome

    1 year

  • Thickness of the layers of the retina with Optical Coherent Tomography(OCT),

    1 year

  • Standard Humphrey Visual Field Test

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seen at the Adolphe de Rothschild Foundation for the first onset of an optic neuritis not related to multiple sclerosis and clinically isolated syndrome

You may qualify if:

  • First onset of an optic neuritis lasting for less than 1 month
  • With a brain MRI that does not meet the MS criteria

You may not qualify if:

  • Contra-indication to MRI
  • Pregnant or lactating woman
  • History of known ipsilateral optic neuritis
  • Ophthalmologic comorbidity in the ipsilateral eye that may interfere with the interpretation of the examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation A. de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Optic Neuritis

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Romain DESCHAMPS, MD

    Fondation A. de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 24, 2019

Study Start

September 14, 2020

Primary Completion

May 23, 2024

Study Completion

May 23, 2024

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations

FR(1)