NCT04451265

Brief Summary

The patient presents to the ophthalmological emergencies and / or to the internal medicine department. NOIA clinical discovery Patient referred in radiology for brain and visual MRI. The two sequences added by the research (8 minutes) will be added to that of the treatment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Oct 2022Mar 2028

First Submitted

Initial submission to the registry

June 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
2.3 years until next milestone

Study Start

First participant enrolled

October 26, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

4.9 years

First QC Date

June 25, 2020

Last Update Submit

December 30, 2025

Conditions

Neuro-Ophthalmology

Outcome Measures

Primary Outcomes (1)

  • Study the sensitivity of the High resolution Diffusion sequence in the detection of NOIA, evaluated by a DWI hypersignal and an ADC hyposignal of the optic nerve

    basline

Interventions

MRIOTHER

Diffusion sequence (8 minutes long) added to the initial MRI

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with suspected NOIA, discussed after clinical examination by a specialist ophthalmologist

You may qualify if:

  • Patient over 18 years old
  • Patient with suspected NOIA, evoked after clinical examination by a specialized ophthalmologist
  • For which a brain and visual MRI is planned
  • Express consent to participate in the study
  • Affiliate or beneficiary of a Social Security scheme

You may not qualify if:

  • Contraindication to MRI (electrical device, metallic foreign body, claustrophobia)
  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU de LILLE

Lille, Lille, 59000, France

NOT YET RECRUITING

Fondation A De Rothschild

Paris, PARIS, 75019, France

RECRUITING

Chu Rouen

Rouen, 76100, France

NOT YET RECRUITING

Central Study Contacts

Amelie YAVCHITZ

CONTACT

0148036431ayavchitz@for.paris

sidney krystal

CONTACT

0148036401skrystal@for.paris

Study Design

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

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 30, 2020

Study Start

October 26, 2022

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

January 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)