Building Research With Artificial Intelligence in Neuro-Ophthalmology (BRAIN)

September 1, 2025 updated by: Fondation Ophtalmologique Adolphe de Rothschild

The research team, recognized as a world leader in Artificial Intelligence for neuro-ophthalmology, has shown that it is possible to diagnose certain neuro-ophthalmologic or neurologic disorders from a single retinal fundus image (Milea et al, New England Journal of Medicine, 2020). However, clinical practice requires identifying a broader spectrum of diseases (inflammatory, ischemic, hereditary, neurodegenerative) within the same analysis.

The main objective is to develop, through a new algorithm capable of classifying multiple disorders from a smaller set of conventional retinal images.

This project meets a significant public health need: the global shortage of neuro-ophthalmologists. It aims to provide healthcare professionals with a rapid triage tool to detect serious and treatable conditions, enabling timely intervention.

The study will include patients with clearly defined neuro-ophthalmologic or neurologic conditions, confirmed diagnoses, and retinal imaging. Clinical, paraclinical, and imaging data collected during standard care will be used, with strict anonymization according to legal and institutional requirements.

Specific Objectives :

  1. Evaluate the performance of a diagnostic classification algorithm trained on retinal images.
  2. Assess the ability to detect multiple pathologies from a single retinal image.
  3. Support the development of advanced computer vision tools for medical diagnostics.

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

  • France
    • France
      • Paris, France, 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:

  • Patients with well-defined neuro-ophthalmologic or neurologic conditions, including different forms of optic neuropathies and various neurodegenerative diseases.
  • Patients with a robust reference diagnosis confirmed by clinical experts.
  • Patients with available retinal fundus images collected during routine care.

Exclusion Criteria:

  • Patients without a confirmed diagnosis or unclear clinical classification.
  • Patients without retinal fundus images or with images that are completely unreadable.
  • Patients whose data cannot be anonymized according to legal and institutional protocols.

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
Diagnostic performance of the Artificial Intelligence algorithm in detecting multiple neuro-ophthalmologic and neurologic conditions from retinal imaging.
Time Frame: baseline
Evaluation of the algorithm's sensitivity, specificity, and area under the receiver operating caracteristics curve for classifying multiple neuro-ophthalmologic and neurologic pathologies using retinal fundus photography and Optical Coherence Tomography images, compared with expert-established reference diagnoses.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE_20230926_8_DMA_BRAIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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