NCT03313817

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 13, 2017

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2024

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

5.9 years

First QC Date

September 25, 2017

Last Update Submit

December 30, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Contrast enhancement of the ophthalmic artery

    Binary variable (yes/no)

    Baseline

  • Presence of a thrombus

    Binary variable (yes/no)

    Baseline

  • Presence of an arterial stenosis of the supra aortic trunks

    Binary variable (yes/no)

    Baseline

  • Hypersignal of the ophthalmic artery in diffusion

    Binary variable (yes/no)

    Baseline

  • Restriction of the apparent diffusion coefficient (ADC) at the optic nerve level and at the papilla level

    Binary variable (yes/no)

    Baseline

Interventions

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.

Eligibility Criteria

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

Adult patients hospitalized for CRAO ≤ 48 hours.

You may qualify if:

  • years of age or older
  • CRAO (onset of symptoms ≤ 48 hours)
  • Consent to participate in the study

You may not qualify if:

  • \- Contraindications to 3 Tesla MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, France

Location

MeSH Terms

Conditions

Retinal Artery OcclusionDisease

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

September 25, 2017

First Posted

October 18, 2017

Study Start

December 13, 2017

Primary Completion

October 24, 2023

Study Completion

January 24, 2024

Last Updated

January 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations