Informations générales (source: ClinicalTrials.gov)
Validation of OphtAI Software Diagnostic Performance for Automated Screening of Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and ARMD: a Multicentre Study
Interventional
N/A
Evolucare Technologies (Voir sur ClinicalTrials)
juin 2023
mars 2024
30 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE HOSPITALIER SUD FRANCILIEN | Alfred Penfornis, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Aix Vision - 13090 - Aix-en-Provence - France | Sébastien Guigou, Dr | Contact (sur clinicalTrials) | |||
| Centre d'examens de santé de la CPAM 93 - Corbeil-Essonnes - France | Philippe Laboulaye, Dr | Contact (sur clinicalTrials) | |||
| Centre Ophtalmologique Brétigny Essonne - 91220 - Brétigny-sur-Orge - France | Bénédicte Dupas, Dr | Contact (sur clinicalTrials) | |||
| CHU Brest - Brest - France | Béatrice Cochener, Pr | Contact (sur clinicalTrials) | |||
| CHU Nantes - 44000 - Nantes - France | Contact (sur clinicalTrials) | ||||
| CHU Toulouse - Toulouse - France | Véronique Pagot-Mathis, Dr | Contact (sur clinicalTrials) | |||
| Clinique Honoré Cave - Montauban - France | Vincent Gualino, Dr | Contact (sur clinicalTrials) | |||
| Diabète Occitanie - 31059 - Toulouse - France | Marie-Christine Chauchard, Dr | Contact (sur clinicalTrials) | |||
| OPHDIAT - 75000 - Paris - Île De France - France | Aude Couturier, Dr | Contact (sur clinicalTrials) | |||
| Retinodiab Bourgogne - Dijon - France | Catherine Creuzot-Garcher, Pr | Contact (sur clinicalTrials) | |||
| Retinodiab Franche-Comté - 90380 - Roppe - France | Pierre Bobey, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
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.