Neuro-OphthalmologyDACODACNCT04451265
Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy
An observational study of Neuro-Ophthalmology, run by Fondation Ophtalmologique Adolphe de Rothschild at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuro-Ophthalmology
- What is being tested?
- MRI
- How many people
- 250 participants
- Where
- 3 sitesFrance
- Study dates
- 26 Oct 2022to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with suspected NOIA, discussed after clinical examination by a specialist ophthalmologist
Who may be able to join
- 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
Who cannot join
- Contraindication to MRI (electrical device, metallic foreign body, claustrophobia)
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
CHU de LILLE
Lille, Lille, 59000
Olivier OUTTERYCK, 0320225050, Olivier.OUTTERYCK@CHRU-LILLE.FR
- Recruiting
Fondation A De Rothschild
Paris, PARIS, 75019
Amelie YAVCHITZ, 0148036431, ayavchitz@for.paris
Candice Sabben, MD, PhD
- Not yet recruiting
Chu Rouen
Rouen, 76100
Emmanuel GERARDIN, 02 32 08 22 50, Emmanuel.Gerardin@chu-rouen.fr
About this study
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.
- Conditions
- Neuro-Ophthalmology
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Diffusion sequence (8 minutes long) added to the initial MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start26 Oct 2022
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro-OphthalmologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451265
- Sponsor's protocol ID
- GPN_2020_6
- Acronym
- DACODAC
- Status last verified
- Dec 2025
- First submitted
- 25 Jun 2020
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy
- ClinicalTrials.gov ID
- NCT04451265
- Acronym / sponsor ID
- DACODAC / GPN_2020_6
- Conditions
- Neuro-Ophthalmology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected NOIA, discussed after clinical examination by a specialist ophthalmologist
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Contraindication to MRI (electrical device, metallic foreign body, claustrophobia)
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIDiffusion sequence (8 minutes long) added to the initial MRI | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Neuro-Ophthalmology
RecruitingObservational study
An Early Prospective Study of the Traq™ Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury
Mild Traumatic Brain Injury, Concussion, Binocular Visual Function
Recruiting
Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease
Visual Field Defect, Peripheral
RecruitingObservational study
Real-World Assessment of VEVYE® for Short-Term Symptom and Sign Improvement of Dry Eye Disease in a Neuro-Ophthalmology Clinic: A 6-Month Prospective Observational Study
Dry Eye
RecruitingObservational study
Safety and Normative Data With Neos™
Neuro-Ophthalmology
Not yet recruitingObservational study
Optic Nerve Head Evaluation Through Multimodal Blood Flow Analysis: a Prospective Observational, Multi-center Study
Neuro-Ophthalmology, Optic Neuropathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuro-Ophthalmology, run by Fondation Ophtalmologique Adolphe de Rothschild at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie YAVCHITZ (0148036431, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.