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NCT Number: NCT06643338

Development of a Deep Learning System for Identification of Neuro-Ophthalmological Conditions on Color Fundus Photographs in Emergency Department

In recent years, artificial intelligence (AI) has been widely integrated into the medical field, contributing in particular to improved patient diagnosis. The BONSAI study, Brain and Optic Nerve Study with AI, in which our team is participating, has successfully demonstrated the ability of AI to identify individual neuro-ophthalmological or neurological pathologies affecting the optic nerves and/or brain, from a simple fundus image.

While this is a promising advance, it remains limited in current clinical practice. Our major challenge is to be able to identify a wider range of optic nerve and/or brain pathologies simultaneously in the same analysis, so as to improve patient management, especially for those referred to emergency departments. Indeed, in the absence of a precise diagnosis, complications can be irreversible and life-threatening.

Among the most alarming clinical signs in the emergency department is papilledema of stasis, which, accompanied by acute headaches, may indicate the presence of intracranial hypertension, inflammatory or ischemic pathology. The latter may be a manifestation of Horton's disease. Our team has developed an AI algorithm to diagnose retinal and optic nerve abnormalities based on retinophotographs taken under ideal conditions during scheduled consultations, and not on images of patients presenting to the emergency department. In hospitals without ophthalmology emergency departments, it is essential that emergency physicians (emergency physicians, general practitioners, neurologists) are able to assess the fundus in the absence of an ophthalmology specialist. This assessment, although part of the general examination, often presents challenges for non-ophthalmologists. The aim of our study is to improve the performance of our AI algorithm so that it can discriminate between different retinal and optic nerve pathologies in the emergency department. We therefore plan to build a database of fundus images by prospectively including patients presenting to the ophthalmology and neurology emergency departments of the Fondation Adolphe de Rothschild Hospital. The performance of the algorithm developed will be evaluated according to standard criteria of sensitivity, specificity, area under the curve (AUC) and accuracy.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient aged 18 and over
  • Presenting to the emergency department of the Fondation Adolphe de Rothschild hospital
  • Express consent to participate in the study
  • Member or beneficiary of a social security scheme

Exclusion criteria

  • Patient under legal protection
  • Pregnant or breast-feeding women

Treatment and study plan

Primary outcomes

  1. Proportion of correct predictions among all positive predictions out of all total predictions of the algorithm (positive + negative)

    Time frame: Day 30

    The gold standard will be the diagnosis made by a senior ophthalmologist on the basis of the patient's medical records consulted at D30 after the emergency visit

Secondary outcomes

  1. Sensitivity of the algorithm for each eye disease

    Time frame: Day 30

    The gold standard will be the diagnosis made by a senior ophthalmologist on the basis of the patient's medical records consulted at D30 after the emergency visit

  2. Specificity of the algorithm for each eye disease

    Time frame: Day 30

    The gold standard will be the diagnosis made by a senior ophthalmologist on the basis of the patient's medical records consulted at D30 after the emergency visit

  3. Area under the curve (AUC) for each eye disease

    Time frame: Day 30

    The gold standard will be the diagnosis made by a senior ophthalmologist on the basis of the patient's medical records consulted at D30 after the emergency visit

Study contacts

Contact information is provided by the study sponsor or research team.

Amelie Yavchitz, Dr

CONTACT

[email protected]

33 148036454

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: DEEP-VISION

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 16, 2024
Registry last updated
Oct 16, 2024

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.

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