Automated screening for eye diseases using AI technology

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.