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OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases — OPHTAI-EVAL  

Glaucoma Clinical Trial

Official title:
Validation of OphtAI Software Diagnostic Performance for Automated Screening of Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and ARMD: a Multicentre Study

Clinical Trial Summary

Evolucare OphtAI is a medical device offering automated, artificial intelligence powered, screening capabilities for Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and AMD, whose performances will by tested through the OphtAI-EVAL.

Clinical Trial Description

OphtAI-Eval: is a prospective, multicentre, post-marketing clinical follow-up study (SCAC) of diagnostic validation (comparative vs gold standard). It aims to: validate the diagnostic performance of the OphtAI software for the automated screening of diabetic retinopathy, diabetic macular edema, glaucoma, ARM and AMD. Evolucare OphtAI is a medical imaging console for ophthalmology, interfaced with Evolucare Imaging. It allows the detection, by statistical learning algorithms, of the following ocular pathologies using photographs of the retina: - Diabetic retinopathy (DR) (including gradation), - Diabetic macular edema (DME) - Age-related macular degeneration (AMD) - Age-related maculopathy (ARM, early form of AMD), - Glaucoma. Evolucare OphtAI, is available on the French market since March 2019. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05752045
Study type Interventional
Source Evolucare Technologies
Contact Ophélie Flageul
Phone 02 23 06 11 13
Email o.flageul@slbpharma.com
Status Recruiting
Phase N/A
Start date June 28, 2023
Completion date March 2024
View Details
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