- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03049514
Study of Arterial Recanalization of the Central Retinal Artery Occlusions (RECANAL)
April 7, 2022 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75019
- Fondation ophtalmique Adolphe de Rothschild
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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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients referred for an central retinal artery occlusion
Description
Inclusion Criteria:
- Central Retinal Artery Occlusion ≤ 24 hours
Exclusion Criteria:
- Retinal Dynamic angiography not performed within 48 hours of onset of symptoms
- Occlusion of a branch of the central retinal artery
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dynamic retinal angiography data at 24 hours (+/- 24 hours)
Time Frame: 24 hours (+/- 24 hours) following the beginning of symptoms
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michaël Obadia, MD, Fondation A De Rothschild
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)
December 23, 2016
Primary Completion (ACTUAL)
April 2, 2022
Study Completion (ACTUAL)
April 2, 2022
Study Registration Dates
First Submitted
February 8, 2017
First Submitted That Met QC Criteria
February 8, 2017
First Posted (ACTUAL)
February 10, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 14, 2022
Last Update Submitted That Met QC Criteria
April 7, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOA_2016_22
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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