Automated screening for eye diseases using AI technology
Validation of OphtAI Software Diagnostic Performance for Automated Screening of Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and ARMD: a Multicentre Study
This study is testing a new AI device to see if it can accurately detect common eye diseases in people during routine eye exams.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1389 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Evolucare Technologies Industry-sponsored |
| Locations | 12 sites (Aix-en-Provence and 11 other locations) |
| Trial ID | NCT05752045 on ClinicalTrials.gov |
What this trial studies
The OphtAI project aims to validate the diagnostic performance of an artificial intelligence-powered medical device designed for the automated screening of various eye diseases, including diabetic retinopathy, diabetic macular edema, glaucoma, age-related macular degeneration, and age-related maculopathy. This multicenter, post-marketing clinical follow-up study will compare the device's performance against established gold standards. Participants will undergo eye fundus imaging to assess the effectiveness of the OphtAI software in detecting these conditions. The study is crucial for determining the reliability of AI in enhancing early diagnosis and treatment of eye diseases.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with Type 1 or Type 2 diabetes who are seeking screening for diabetic retinopathy.
Not a fit: Patients with known diabetic retinopathy more severe than minimal or those with other significant eye conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and efficient screening for eye diseases, potentially preventing vision loss in diabetic patients.
How similar studies have performed: Other studies have shown promise in using AI for automated screening of eye diseases, indicating a growing field of research with potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aix-en-Provence and 11 other locations
- Centre Aix Vision — Aix-en-Provence, France (Recruiting)
- CHU Brest — Brest, France (Recruiting)
- Centre Ophtalmologique Brétigny Essonne — Brétigny-sur-Orge, France (Recruiting)
- CH SUD Francilien Corbeil Essonne — Corbeil Essonnes, France (Recruiting)
- Centre d'examens de santé de la CPAM 93 — Corbeil-Essonnes, France (Recruiting)
- Retinodiab Bourgogne — Dijon, France (Recruiting)
- Clinique Honoré Cave — Montauban, France (Not_yet_recruiting)
- CHU Nantes — Nantes, France (Active_not_recruiting)
- Retinodiab Franche-Comté — Roppe, France (Not_yet_recruiting)
- Diabète Occitanie — Toulouse, France (Recruiting)
- CHU Toulouse — Toulouse, France (Recruiting)
- Ophdiat — Paris, Île De France, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Aude Couturier, Dr — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Ophélie Flageul
- Email: o.flageul@slbpharma.com
- Phone: 02 23 06 11 13
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.