OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases

N/AUnknownNCT05752045

Evolucare Technologies1,389 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

1,389

Conditions

Diabetic Retinopathy Diabetic Macular Edema Age-Related Macular Degeneration Age-related Maculopathy Glaucoma

Interventions

Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical DeviceDEVICE

Double ophthalmological imaging capture of eye fundus with different fundus camera to screen patient for various eye diseases.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Doesn't not accept healthy volunteers as diabetic patients are needed, still they may be free of any eye diseases. Inclusion Criteria: The characteristics required for a subject to take part in the research are * Male or female over 18, * Type 1 or 2 diabetic, * Presenting for screening for diabetic retinopathy, * Beneficiary of a social security scheme, * For whom written consent has been obtained for participation in the protocol. Exclusion Criteria: The following characteristics do not allow the subject to take part in the research: * Patient with known DR, more severe than "minimal", including having been treated, * Any other condition that, in the opinion of the health professionals, may interfere with their ability to complete the study or may present a significant risk, * Presence of social, medical and/or psychological factors that may compromise the patient's adherence to the protocol, * Simultaneously participating in another clinical research protocol or having recently participated in another research study for which the exclusion period would not be completed. Patients who participate in this research will not be able to participate in another research at the same time. However, there is no exclusion period at the end of this research for participation in any other study.

Locations (12)

Centre Aix Vision

Aix-en-Provence, France

RECRUITING

CHU Brest

Brest, France

RECRUITING

Outcomes

Primary Outcomes

Referable Diabetic Retinopathy screening sensitivity/specificity

Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha and RDR-OphDiaT\_full algorithms

Time frame: 1 year

Secondary Outcomes

Diabetic retinopathy grading sensitivity/specificity

Diabetic retinopathy grading performance (OphtAI software vs Expert reader) for each grading sub algorithms (sensitivity/specificity) and globally (accuracy/agreement ratio)

Time frame: 1 year

Diabetic retinopathy grading + RDR-EOphtha algorithms combination sensitivity/specificity for RDR detection

Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha and RD grading algorithms combination

Time frame: 1 year

Diabetic retinopathy grading + RDR-OphDiaT_full algorithms combination sensitivity/specificity for RDR detection

Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-OphDiaT\_full and RD grading algorithms combination

Time frame: 1 year

Diabetic retinopathy grading + RDR-EOphtha +DME algorithms combination sensitivity/specificity for RDR detection

Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha, RD grading and DME algorithms combination

Time frame: 1 year

Diabetic retinopathy grading + RDR-OphDiaT_full +DME algorithms combination sensitivity/specificity for RDR detection

Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-OphDiaT\_full , RD grading and DME algorithms combination

Central Contacts

Ophélie Flageul

CONTACT

02 23 06 11 13 o.flageul@slbpharma.com

Laurent Borderie

CONTACT

0762879928 l.borderie@evolucare.com

Data from ClinicalTrials.gov

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