Building Research With Artificial Intelligence in Neuro-Ophthalmology

NCT ID: NCT06390579

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

693 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Deep learning algorithm applied on retrospectively collected color fundus photographs

Deep learning algorithm applied on retrospectively collected color fundus photographs

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital Fondation Adolphe de Rothschild

Paris, France, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 40576025 (View on PubMed)

Other Identifiers

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CE_20230926_8_DMA_BRAIN

Identifier Type: -

Identifier Source: org_study_id

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