Diagnostic Accuracy of Optimized Diffusion-Weighted Imagi... | NCT04451265

Studies
Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy

NCT04451265

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Recruiting

Last Update Posted

Jan 5, 2026Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Neuro-Ophthalmology

Interventions

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

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 26, 2022Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Mar 2028Estimated

First Submitted Date

Jun 25, 2020

First Submission Date that Met QC Criteria

Jun 25, 2020

First Posted Date

Jun 30, 2020Actual

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

Dec 30, 2025

Last Update Posted Date

Jan 5, 2026Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

250Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Other	Diffusion sequence (8 minutes long) added to the initial MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amelie YAVCHITZ	Contact	0148036431		ayavchitz@for.paris
sidney krystal	Contact	0148036401		skrystal@for.paris

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de LILLE	Not yet recruiting	Lille	Lille	59000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided