Preliminary Assessment of an Automated Tool for Diabetic Retinopathy Screening

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.

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Key information

Conditions

Diabetic Retinopathy (DR) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

22 years old or older
diabetes or diabetic retinopathy
understand the study information and able to sign a consent form

Exclusion criteria

cannot tolerate eye imaging tests
laser treatment or injections
eye surgery, except for simple cataract surgery
currently involved in another study
pregnant
cannot or do not want to have your eyes dilated
photodynamic therapy within the last 90 days

Treatment and study plan

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

Device

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

Primary outcomes

Number of subjects whose results provided by the automatic AI-based tool match the reading center grading for the identification of referable diabetic eye disease (more than mild DR).

Time frame: 1-day visit

Secondary outcomes

percentage of eyes for which the AI-based automatic tool produced a result

Time frame: 1-day visit

Study contacts

Contact information is provided by the study sponsor or research team.

Rui

CONTACT

[email protected]

00393357442593

Rumiato

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centervue SpA

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 11, 2026
Registry last updated: Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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