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Preliminary Assessment of an Automated Tool for Diabetic Retinopathy Screening

NCT07404657 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 198

Last updated 2026-02-11

No results posted yet for this study

Summary

This study is being done to evaluate the performance of a software that uses artificial intelligence to analyze photographs of the retina to help detect diabetic retinopathy. The study will also assess the safety of the software in combination with a fundus camera already available on the market. This software analyzes retinal photographs to detect more than mild diabetic retinopathy in adults with diabetes. The results will be compared to expert human evaluations.

Conditions

  • Diabetic Retinopathy (DR)

Interventions

DEVICE

automatic analysis of fundus images performed by the software tool based on artificial intelligence

the duration of the intervention is the analysis performed by the software tool based on fundus images acquired

Sponsors & Collaborators

  • Centervue SpA

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-04-30
Completion
2026-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07404657 on ClinicalTrials.gov