OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases
NCT ID: NCT05752045
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1389 participants
INTERVENTIONAL
2023-06-28
2024-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Diabetic patient group assessed for multiple eye diseases
Each patient eye disease status will be assessed by expert readers so to provide ground truth against which algorithms performances will be assessed
Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device
Double ophthalmological imaging capture of eye fundus with different fundus camera to screen patient for various eye diseases.
Interventions
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Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device
Double ophthalmological imaging capture of eye fundus with different fundus camera to screen patient for various eye diseases.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Slb Pharma
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
BPIfrance
OTHER
Evolucare Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Aude Couturier, Dr
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Centre Aix Vision
Aix-en-Provence, , France
CHU Brest
Brest, , France
Centre Ophtalmologique Brétigny Essonne
Brétigny-sur-Orge, , France
CH SUD Francilien Corbeil Essonne
Corbeil-Essonnes, , France
Centre d'examens de santé de la CPAM 93
Corbeil-Essonnes, , France
Retinodiab Bourgogne
Dijon, , France
Clinique Honoré Cave
Montauban, , France
CHU Nantes
Nantes, , France
Retinodiab Franche-Comté
Roppe, , France
Diabète Occitanie
Toulouse, , France
CHU Toulouse
Toulouse, , France
OPHDIAT
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-A01813-40
Identifier Type: -
Identifier Source: org_study_id
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