NCT06643338 Development of a Deep Learning System for Identification of Neuro-Ophthalmological Conditions on Color Fundus Photographs in Emergency Department
| NCT ID | NCT06643338 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
| Condition | Eye Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-09-09 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06643338 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Eye Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06643338 currently recruiting?
Yes, NCT06643338 is actively recruiting participants. Contact the research team at ayavchitz@for.paris for enrollment information.
Where is the NCT06643338 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06643338 clinical trial?
NCT06643338 is sponsored by Fondation Ophtalmologique Adolphe de Rothschild. The trial plans to enroll 1,000 participants.