| Registry | NCT06390579, acronym BRAIN |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 693 (Actual) |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild (Network) |
| Conditions | Optic Neuropathy, Optic Neuropathy, Ischemic, Optic Neuritis, Optic Nerve Diseases, Papilledema, Optic Atrophy, Brain Tumors, Retinal Photograph, Artificial Intelligence (AI), Machine Learning, Deep Learning |
| Interventions | Deep learning algorithm applied on retrospectively collected color fundus photographs (Other) |
| Dates | start 2023-10-01, primary completion 2024-02-01, completion 2024-02-01, first posted 2024-04-30, last updated 2025-09-08 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Optic Neuropathy All trials for Optic Neuropathy, Ischemic All trials of Deep learning algorithm applied on retrospectively collected color fundus photographs
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.
Sex: All
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Hopital Fondation Adolphe de Rothschild | Paris, France | France |