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Recruiting
NCT07844317
Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy
Conditions: Diabetic Retinopathy (DR)
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: Yes
Enrollment: 800
Sponsor: Digital Diagnostics, Inc.
Location: Rovia Site Network Jacksonville Florida
Summary
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07844317). StuddyBuddy aggregates publicly available trial information.