Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis (OCTON2)

February 11, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Evaluation and Follow-up of Optic Neuritis Not Related to Multiple Sclerosis

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Recruiting
        • Fondation A. de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity (ETDRS scale)
Time Frame: 1 year
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),
Time Frame: 1 year
1 year
Standard Humphrey Visual Field Test
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 14, 2020

Primary Completion (ANTICIPATED)

September 14, 2024

Study Completion (ANTICIPATED)

September 14, 2024

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (ACTUAL)

May 24, 2019

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 11, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDS_2019_8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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