Skip to main content
Clinical Trials/NCT06643338
NCT06643338
Recruiting
Not Applicable

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

Fondation Ophtalmologique Adolphe de Rothschild1 site in 1 country1,000 target enrollmentSeptember 9, 2024
ConditionsEye Diseases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eye Diseases
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Enrollment
1000
Locations
1
Primary Endpoint
Proportion of correct predictions among all positive predictions out of all total predictions of the algorithm (positive + negative)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 9, 2024
End Date
October 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Sensitivity of the algorithm for each eye disease(Day 30)
  • Specificity of the algorithm for each eye disease(Day 30)
  • Area under the curve (AUC) for each eye disease(Day 30)

Study Sites (1)

Loading locations...

Similar Trials