OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases

Last updated: September 25, 2023
Sponsor: Evolucare Technologies
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Macular Edema

Retina

Glaucoma

Treatment

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

Clinical Study ID

NCT05752045
2022-A01813-40
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Doesn't not accept healthy volunteers as diabetic patients are needed, still they may befree 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

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 interferewith their ability to complete the study or may present a significant risk,
  • Presence of social, medical and/or psychological factors that may compromise thepatient's adherence to the protocol,
  • Simultaneously participating in another clinical research protocol or having recentlyparticipated in another research study for which the exclusion period would not becompleted. Patients who participate in this research will not be able to participate in anotherresearch at the same time. However, there is no exclusion period at the end of thisresearch for participation in any other study.

Study Design

Total Participants: 1389
Treatment Group(s): 1
Primary Treatment: Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device
Phase:
Study Start date:
June 28, 2023
Estimated Completion Date:
March 31, 2024

Study 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.

Connect with a study center

  • OPHDIAT

    Paris, Île De France 75000
    France

    Site Not Available

  • Centre Aix Vision

    Aix-en-Provence, 13090
    France

    Active - Recruiting

  • CHU Brest

    Brest,
    France

    Active - Recruiting

  • Centre Ophtalmologique Brétigny Essonne

    Brétigny-sur-Orge, 91220
    France

    Active - Recruiting

  • CH SUD Francilien Corbeil Essonne

    Corbeil Essonnes, 91100
    France

    Active - Recruiting

  • Centre d'examens de santé de la CPAM 93

    Corbeil-Essonnes,
    France

    Active - Recruiting

  • Retinodiab Bourgogne

    Dijon,
    France

    Active - Recruiting

  • Clinique Honoré Cave

    Montauban,
    France

    Site Not Available

  • CHU Nantes

    Nantes, 44000
    France

    Site Not Available

  • Retinodiab Franche-Comté

    Roppe, 90380
    France

    Site Not Available

  • CHU Toulouse

    Toulouse,
    France

    Active - Recruiting

  • Diabète Occitanie

    Toulouse, 31059
    France

    Active - Recruiting

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