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

Evolucare Technologies

Status: Enrolling

Conditions: Age-Related Macular Degeneration; Age-related Maculopathy; Diabetic Macular Edema; Glaucoma; Diabetic Retinopathy

Treatments: Device: Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05752045

2022-A01813-40

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,389 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,389 participants in 1 patient group

Diabetic patient group assessed for multiple eye diseases

Other group

Description:

Each patient eye disease status will be assessed by expert readers so to provide ground truth against which algorithms performances will be assessed

Treatment:

Device: Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device