Skip to main content
OpenTrials
Completed

NCT Number: NCT06390579

Building Research With Artificial Intelligence in Neuro-Ophthalmology

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deep learning algorithm applied on retrospectively collected color fundus photographs

Other

Deep learning algorithm applied on retrospectively collected color fundus photographs

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: BRAIN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.