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CompletedNCT06390579BRAINUpdated Sep 8, 2025

Building Research With Artificial Intelligence in Neuro-Ophthalmology

An observational study in Optic Neuropathy, Optic Neuropathy, Ischemic and Optic Neuritis, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
693
Sex
All
01

Study summary

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.
02

Conditions studied

  • Optic Neuropathy
  • Optic Neuropathy, Ischemic
  • Optic Neuritis
  • Optic Nerve Diseases
  • Papilledema
  • Optic Atrophy
  • Brain Tumors
  • Retinal Photograph
  • Artificial Intelligence (AI)
  • Machine Learning
  • Deep Learning

Keywords

  • fundus imaging
  • automated diagnosis
  • multi-class classification
  • clinical decision support
03

In context

Optic Nerve Diseases

61 studies on the registry are indexed under Optic Nerve Diseases; 22 are open to participants now.

This study's enrollment of 693 is above the median of 56 across 21 observational studies indexed under Optic Nerve Diseases.

Browse Optic Nerve Diseases studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Color fundus photographs taken within 30 days from the date of onset

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
693 participants (actual)
Patient registry
No

Interventions

  • OtherDeep learning algorithm applied on retrospectively collected color fundus photographs

    Deep learning algorithm applied on retrospectively collected color fundus photographs

06

What researchers measure

Primary outcomes

  1. Diagnostic performance of the Artificial Intelligence algorithm in detecting multiple neuro-ophthalmologic and neurologic conditions from retinal imaging.

    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.

    Time frame: baseline

07

Study locations

1 site
  • Hopital Fondation Adolphe de Rothschild
    Paris, France 75019, France
08

References and documents

Publications

  • Gungor A, Sarbout I, Gilbert AL, Hamann S, Lebranchu P, Hobeanu C, Gohier P, Vignal-Clermont C, Dumitrascu OM, Cohen SY, Lagreze WA, Feltgen N, van der Heide F, Lamirel C, Jonas JB, Obadia M, Racoceanu D, Milea D. Artificial Intelligence-Based Detection of Central Retinal Artery Occlusion Within 4.5 Hours on Standard Fundus Photographs. J Am Heart Assoc. 2025 Jul;14(13):e041441. doi: 10.1161/JAHA.124.041441. Epub 2025 Jun 27. PubMed 40576025 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06390579
Responsible party
Sponsor
First posted
Apr 30, 2024
Start date
Oct 1, 2023
Primary completion
Feb 1, 2024
Completion
Feb 1, 2024
Last update
Sep 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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