Retinal Artery OcclusionI-RECANALNCT03313817
Pre and Post-arterial Recanalization Imaging of Central Retinal Artery Occlusions (CRAO)
An observational study of Retinal Artery Occlusion and Magnetic Resonance Imaging, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke at the retinal level. They share the same risk factors and common pathology. The diagnosis of a CRAO is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Artery Occlusion, Magnetic Resonance Imaging, Diagnosis
- What is being tested?
- Additional MRI sequences
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2017to 24 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients hospitalized for CRAO ≤ 48 hours.
Who may be able to join
- 18 years of age or older
- CRAO (onset of symptoms ≤ 48 hours)
- Consent to participate in the study
Who cannot join
- Contraindications to 3 Tesla MRI
Trial locations and contacts
1 site in 1 country.
About this study
Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke at the retinal level. They share the same risk factors and common pathology. The diagnosis of a CRAO is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia.
Small studies have highlighted the value of cerebral MRI (Magnetic Resonance Imaging) in CRAO with almost 25% of ischemic strokes found on diffusion sequences and the demonstration of a correlation between anomalies in diffusion sequence and the probability of a pathology with a high risk of recurrence (carotid stenosis or emboligenic cardiopathy). But there are usually few radiological signs that allow a direct positive diagnosis of CRAO, an etiologic diagnosis or a prognosis. This descriptive study will focus on CRAO at the diagnostic and post-treatment phases in the short and medium term, in order to (i) identify imaging etiologic signs of CRAO with specific sequences from a 3 Tesla MRI, (ii) identify positive diagnostic signs of CRAO with the same specific sequences, (iii) correlate these signs with the visual prognosis one month after the CRAO.
- Being tested
- Additional MRI sequences
- Medical subject headings
- Retinal Artery Occlusion, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional MRI sequencesDevice
Patients will be hospitalized for suspicion of CRAO. An "optimized" MRI will be performed with specific sequences: 3D T1 MSDE (Motion Sensitized Driven Equilibrium) "dark blood"; 3D Optimized diffusion centered on the optic nerves; 3D PD T1 after injection. A consultation of ophthalmology and a control MRI will be carried out one month after the CRAO. Again, specific sequences will be added: 3D T1 MSDE (Motion Sensitized Driven Equilibrium) "dark blood"; 3D Optimized diffusion centered on the optic nerves; DTI (Diffusion Tensor Imaging); 3D PD T1 after injection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast enhancement of the ophthalmic artery
Binary variable (yes/no)
Measured: Baseline
Presence of a thrombus
Binary variable (yes/no)
Measured: Baseline
Presence of an arterial stenosis of the supra aortic trunks
Binary variable (yes/no)
Measured: Baseline
Hypersignal of the ophthalmic artery in diffusion
Binary variable (yes/no)
Measured: Baseline
Restriction of the apparent diffusion coefficient (ADC) at the optic nerve level and at the papilla level
Binary variable (yes/no)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start13 Dec 2017
- Primary completion24 Oct 2023
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Artery OcclusionStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313817
- Sponsor's protocol ID
- ALR_2017_17
- Acronym
- I-RECANAL
- Status last verified
- Dec 2025
- First submitted
- 25 Sep 2017
- 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
- Pre and Post-arterial Recanalization Imaging of Central Retinal Artery Occlusions (CRAO)
- ClinicalTrials.gov ID
- NCT03313817
- Acronym / sponsor ID
- I-RECANAL / ALR_2017_17
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 18 Oct 2017 (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.
Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke at the retinal level. They share the same risk factors and common pathology. The diagnosis of a CRAO is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia.
Small studies have highlighted the value of cerebral MRI (Magnetic Resonance Imaging) in CRAO with almost 25% of ischemic strokes found on diffusion sequences and the demonstration of a correlation between anomalies in diffusion sequence and the probability of a pathology with a high risk of recurrence (carotid stenosis or emboligenic cardiopathy). But there are usually few radiological signs that allow a direct positive diagnosis of CRAO, an etiologic diagnosis or a prognosis. This descriptive study will focus on CRAO at the diagnostic and post-treatment phases in the short and medium term, in order to (i) identify imaging etiologic signs of CRAO with specific sequences from a 3 Tesla MRI, (ii) identify positive diagnostic signs of CRAO with the same specific sequences, (iii) correlate these signs with the visual prognosis one month after the CRAO.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized for CRAO ≤ 48 hours.
Key inclusion criteria (3 listed)
- 18 years of age or older
- CRAO (onset of symptoms ≤ 48 hours)
- Consent to participate in the study
Key exclusion criteria (1 listed)
- Contraindications to 3 Tesla MRI
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 |
|---|---|---|
| Additional MRI sequencesPatients will be hospitalized for suspicion of CRAO. An "optimized" MRI will be performed with specific sequences: 3D T1 MSDE (Motion Sensitized Driven Equilibrium) "dark blood"; 3D Optimized diffusion centered on the optic nerves; 3D PD T1 after injection. A consultation of ophthalmology and a control MRI will be carried out one month after the CRAO. Again, specific sequences will be added: 3D T1 MSDE (Motion Sensitized Driven Equilibrium) "dark blood"; 3D Optimized diffusion centered on the optic nerves; DTI (Diffusion Tensor Imaging); 3D PD T1 after injection. | Device | – |
Primary outcome
Contrast enhancement of the ophthalmic artery
Time frame: Baseline
Binary variable (yes/no)
Presence of a thrombus
Time frame: Baseline
Binary variable (yes/no)
Presence of an arterial stenosis of the supra aortic trunks
Time frame: Baseline
Binary variable (yes/no)
Hypersignal of the ophthalmic artery in diffusion
Time frame: Baseline
Binary variable (yes/no)
Restriction of the apparent diffusion coefficient (ADC) at the optic nerve level and at the papilla level
Time frame: Baseline
Binary variable (yes/no)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Artery Occlusion and Magnetic Resonance Imaging, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site 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 3 inclusion and 1 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: finished, 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast enhancement of the ophthalmic artery (time frame: Baseline). The study lists 5 primary outcomes in all. 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.