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NOT YET RECRUITING
NCT07404657

Preliminary Assessment of an Automated Tool for Diabetic Retinopathy Screening

Sponsor: Centervue SpA

View on ClinicalTrials.gov

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.

Official title: Preliminary Assessment of iCare RETCAD as an Automated Tool for Diabetic Retinopathy Screening

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

198

Start Date

2026-02

Completion Date

2026-04

Last Updated

2026-02-11

Healthy Volunteers

No

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