NCT03049514

Brief Summary

Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke (IS) at the retinal level. They share the same risk factors and common pathology. Their incidence is lower (8.5 / 100,000) and the functional prognosis is unfavorable in 80% of cases with visual acuity (VA) \<1/10. The diagnosis of an CRAO is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia. There is no data on early retinal arterial recanalization after CRAO, nor on the relationship between early recanalization (spontaneous or post-thrombolysis) and visual prognosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

5.3 years

First QC Date

February 8, 2017

Last Update Submit

April 7, 2022

Conditions

Keywords

ThrombolysisRecanalizationDynamic retinal angiography

Outcome Measures

Primary Outcomes (1)

  • Dynamic retinal angiography data at 24 hours (+/- 24 hours)

    Proportion of patients with early arterial recanalization.The recanalization rate will be compared between thrombolysed patients and non-thrombolysed patients

    24 hours (+/- 24 hours) following the beginning of symptoms

Eligibility Criteria

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

Patients referred for an central retinal artery occlusion

You may qualify if:

  • Central Retinal Artery Occlusion ≤ 24 hours

You may not qualify if:

  • Retinal Dynamic angiography not performed within 48 hours of onset of symptoms
  • Occlusion of a branch of the central retinal artery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation ophtalmique Adolphe de Rothschild

Paris, 75019, France

Location

Related Publications (1)

  • Abdelmassih Y, Mauget-Faysse M, Seners P, Milea D, Hallali G, Guillaume J, Lecler A, Vignal C, Le Mer Y, Paques M, Bonnin S, Obadia M. Early reperfusion in patients with acute retinal artery occlusion: A multicenter prospective study. Int J Stroke. 2025 Mar;20(3):338-346. doi: 10.1177/17474930241306692. Epub 2024 Dec 24.

MeSH Terms

Conditions

Retinal Artery Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Michaël Obadia, MD

    Fondation A de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 10, 2017

Study Start

December 23, 2016

Primary Completion

April 2, 2022

Study Completion

April 2, 2022

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations