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ClinicalTrials.gov ID

NCT05752045

Lead Sponsor

Evolucare TechnologiesINDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,389Estimated

Last Update Posted

Sep 28, 2023Actual

Start Date

Jun 28, 2023Actual

Primary Completion Date

Oct 2023Estimated

Completion Date

Mar 2024Estimated

Official Title

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

Brief 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.

Detailed 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.

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

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Primary Purpose

Screening

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Evolucare TechnologiesINDUSTRY

Collaborators

Slb PharmaOTHER

Assistance Publique - Hôpitaux de ParisOTHER

BPIfranceOTHER

beatrice.cochener@ophtalmologie-chu29.fr

pagot-mathis.v@chu-toulouse.fr