- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06390579
Automated Central Retinal Artery Occlusion Diagnosis on Fundus Photographs (BRAIN)
April 29, 2024 updated by: Fondation Ophtalmologique Adolphe de Rothschild
Early Detection of Central Retinal Artery Occlusion Within 4.5 Hours of Visual Loss: Deep Learning Method Applied on Fundus Photographs
Acute central retinal artery occlusion is associated with a poor prognosis and optimal treatment is not defined as randomized control trials struggle to enroll patients in part due to delayed diagnostic.
Patient lack of knowledge and difficult access to ophthalmologists in emergency situations delay the diagnostic.
A simple, rapid and widely accessible method that can recognize acute central retinal artery occlusion in color fundus photographs could benefit patients and doctors.The prurpose of this study is to develop, train and test a deep learning system.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
693
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
- Hôpital Fondation 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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Color fundus photographs taken within 30 days from the date of onset
Description
Inclusion Criteria:
- Color fundus photographs taken within 30 days from the date of onset
- diagnosis confirmed by the provider's expertise in identifying clinical symptoms and signs.
Exclusion Criteria:
- photographs with unconfirmed diagnosis
- duplicates
- photographs with combined retinal conditions
- photographs taken after thrombolysis.
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 |
---|---|---|
Area under the receiver operating characteristic curve
Time Frame: baseline
|
Area under the receiver operating characteristic curve
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 1, 2023
Primary Completion (Actual)
February 1, 2024
Study Completion (Actual)
February 1, 2024
Study Registration Dates
First Submitted
April 25, 2024
First Submitted That Met QC Criteria
April 29, 2024
First Posted (Actual)
April 30, 2024
Study Record Updates
Last Update Posted (Actual)
April 30, 2024
Last Update Submitted That Met QC Criteria
April 29, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE_20230926_8_DMA_BRAIN
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.
Clinical Trials on CRAO - Central Retinal Artery Occlusion
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University of TorontoOntario Research FundUnknownCentral Retinal Vein Occlusion | Branch Retinal Vein Occlusion | Central Retinal Artery Occlusion | Branch Retinal Artery OcclusionCanada
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Oslo University HospitalRecruitingCentral Retinal Artery OcclusionDenmark, Norway, Belgium, Sweden, Finland, Ireland, Lithuania, Australia, Austria
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Fondation Ophtalmologique Adolphe de RothschildCompletedCentral Retinal Artery OcclusionFrance
-
Xinhua Hospital, Shanghai Jiao Tong University...RecruitingSafety and Efficacy After Selective Intra-arterial Thrombolysis for Central Retinal Artery OcclusionCentral Retinal Artery OcclusionChina
-
Asociación para Evitar la Ceguera en MéxicoUnknownCentral Retinal Artery OcclusionMexico
-
University Hospital TuebingenRecruitingCentral Retinal Artery OcclusionGermany
-
Nantes University HospitalCompleted
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Kyoto Drug Discovery and Development Co., Ltd.RecruitingCentral Retinal Artery OcclusionUnited States
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Xinhua Hospital, Shanghai Jiao Tong University...CompletedVisual Field | Central Retinal Artery Occlusion | Intra-arterial ThrombolysisChina
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Wills EyeCenters for Disease Control and Prevention; Westat; Public Health Management... and other collaboratorsCompletedOcular Hypertension | Glaucoma | Macular Degeneration | Diabetic Retinopathy | Central Retinal Vein Occlusion | Cataract | Branch Retinal Vein Occlusion | Glaucoma Suspect | Central Retinal Artery Occlusion | Drusen | Branch Retinal Arterial Occlusion | Epi-retinal Membrane | Loss of VisionUnited States