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

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

Recruiting
22 years and older
All
Phase N/A

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Overview

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

Eligibility

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.

Study details
    Diabetic Retinopathy (DR)

NCT07844317

Digital Diagnostics, Inc.

20 October 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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