Automated Central Retinal Artery Occlusion Diagnosis on Fundus Photographs (BRAIN)

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

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

      • Paris, France, 75019
        • Hôpital Fondation Adolphe de Rothschild

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

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

3
Subscribe