Optical Coherence Tomography and Optic Neuritis Not Relat... | NCT03963310

Studies
Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis

NCT03963310

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Jun 25, 2025Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Optic Neuritis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 14, 2020Actual

Primary Completion Date

May 23, 2024Actual

Completion Date

May 23, 2024Actual

First Submitted Date

May 20, 2019

First Submission Date that Met QC Criteria

May 22, 2019

First Posted Date

May 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2025

Last Update Posted Date

Jun 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Romain DESCHAMPS, MD	Fondation A. de Rothschild	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation A. de Rothschild		Paris		75019	France

Condition Browse Module

MeSH Terms

ID	Term
D009902	Optic Neuritis

Ancestor Terms

ID	Term
D009901	Optic Nerve Diseases
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided