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← Trials
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Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy

Recruitingn/aAges 22 Years - anyAllDigital Diagnostics, Inc.
NCT07844317 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 22 years of age or older * Diagnosis of DM * Ability to understand and willing to sign a written ICF Exclusion Criteria: Participants may be excluded if they have significant ocular conditions or prior ocular treatments that could interfere with retinal imaging or study assessments; are currently participating in another interventional ophthalmic clinical trial; have medical conditions that may affect study participation or data interpretation; are pregnant; or have contraindications to study-related imaging procedures.
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What it tests

  • SaMD intended for the detection of diabetic retinopathy in adults with diabetes.
  • An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes.
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Where

1 site
Rovia Site Network
Jacksonville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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