Optical Coherence Tomography and Optic Neuritis (OCTON) (OCTON)

June 20, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Optical Coherence Tomography for the Etiological Diagnosis of Inflammatory Optic Neuritis

Optic neuritis (ON) can remain isolated or reveal a widespread and chronic disease of the central nervous system (CNS), a multiple sclerosis (MS) or, more rarely, a Devic's neuromyelitis optica (NMO) or a systemic disease.

The optical coherence tomography (OCT) is a retinal imaging technique to measure the thickness of the retina and its different layers with an accuracy of 4-6 µM.

Costello et al have shown that approximately 75% of 54 MS patients have developed within 3 to 6 months after a ON a loss of 10 to 40 µM in the thickness of the peripapillary retinal nerve fiber layer (RNFL).

The etiologic diagnosis of ON has been transformed in recent years. MS can now be diagnosed by McDonald's MRI criteria and NMO by the AQP4 antibodies (anti-aquaporin- 4) antibodies and the anti-MOG (myelin-oligodendrocyte glycoprotein) antibodies.

The diagnosis and prognosis value of the OCT in patients with ON is not well known

Study Overview

Status

Completed

Conditions

Optical Neuritis

Study Type

Observational

Enrollment (Actual)

120

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
- Ile De France
  - Paris, Ile De France, France, 75019
    - Fondation Ophtalmologique Adolphe 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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients seen at the Adolphe de Rothschild ophthalmological foundation for the first onset of an optical neuritis

Description

Inclusion Criteria:

first onset of an optical neuritis lasting for less than 3 months

Exclusion Criteria:

Contra-indication to MRI
Patient opposed to participation in the study
Pregnant or lactating woman
Patient under a measure of legal protection
Absence of affiliation to social security or universal health coverage (CMU)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity of the OCT, expressed as a percentage, for the etiological diagnosis of optical neuritis Time Frame: One year	One 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)

October 5, 2015

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

October 9, 2015

First Submitted That Met QC Criteria