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NCT05752045
OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases
Conditions: Diabetic Retinopathy, Diabetic Macular Edema, Age-Related Macular Degeneration, Age-related Maculopathy, Glaucoma
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 1389
Sponsor: Evolucare Technologies
Location: France
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
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 areMale 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.
Source: ClinicalTrials.gov (NCT05752045). StuddyBuddy aggregates publicly available trial information.