Preliminary Assessment of an Automated Tool for Diabetic Retinopathy Screening

ConditionDiabetic Retinopathy (DR)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age22+

SponsorCentervue SpA

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

22 years old or older

diabetes or diabetic retinopathy

understand the study information and able to sign a consent form

Disqualifiers

cannot tolerate eye imaging tests

laser treatment or injections

eye surgery, except for simple cataract surgery

currently involved in another study

Trial population

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

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

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

Treatment groups

No treatment groups listed

Trial outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centervue SpA

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: