About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Patient under legal protection
Pregnant or breast-feeding women
Trial population
Adult patients presenting to the emergency department of the Fondation Adolphe de Rothschild hospital with no signs of infection and/or ocular allergy (runny eye, red eye).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Proportion of correct predictions among all positive predictions out of all total predictions of the algorithm (positive + negative)
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
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
Specificity of the algorithm for each eye disease
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
Area under the curve (AUC) for each eye disease
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.