- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04451265
Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy (DACODAC)
December 30, 2025 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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.
Study Overview
Study Type
Observational
Enrollment (Estimated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: sidney krystal
- Phone Number: 0148036401
- Email: skrystal@for.paris
Study Contact Backup
- Name: Amélie YAVCHITZ
- Phone Number: 0148036431
- Email: ayavchitz@for.paris
Study Locations
-
-
-
Rouen, France, 76100
- Not yet recruiting
- CHU Rouen
-
Contact:
- Emmanuel GERARDIN
- Phone Number: 02 32 08 22 50
- Email: Emmanuel.Gerardin@chu-rouen.fr
-
-
Lille
-
Lille, Lille, France, 59000
- Not yet recruiting
- CHU de LILLE
-
Contact:
- Olivier OUTTERYCK
- Phone Number: 0320225050
- Email: Olivier.OUTTERYCK@CHRU-LILLE.FR
-
-
PARIS
-
Paris, PARIS, France, 75019
- Recruiting
- Fondation A de Rothschild
-
Principal Investigator:
- Candice Sabben, MD, PhD
-
Principal Investigator:
- Pierre Seners, MD, PhD
-
Contact:
- Amélie YAVCHITZ
- Phone Number: 0148036431
- Email: ayavchitz@for.paris
-
-
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
N/A
Sampling Method
Probability Sample
Study Population
Patients with suspected NOIA, discussed after clinical examination by a specialist ophthalmologist
Description
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
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: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: basline
|
basline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 26, 2022
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
March 1, 2028
Study Registration Dates
First Submitted
June 25, 2020
First Submitted That Met QC Criteria
June 25, 2020
First Posted (Actual)
June 30, 2020
Study Record Updates
Last Update Posted (Actual)
January 5, 2026
Last Update Submitted That Met QC Criteria
December 30, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GPN_2020_6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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