Preliminary Assessment of an Automated Tool for Diabetic Retinopathy Screening

February 5, 2026 updated by: Centervue SpA

Preliminary Assessment of iCare RETCAD as 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

population attending a primary-care facility with diagnosis of diabetes mellitus and/or past diagnosis of diabetic retinopathy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1-day visit

Secondary Outcome Measures

Outcome Measure
Time Frame
percentage of eyes for which the AI-based automatic tool produced a result
Time Frame: 1-day visit
1-day visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centervue SpA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RETCAD-PVAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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