Preliminary Assessment of an Automated Tool for Diabetic Retinopathy Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: automatic analysis of fundus images performed by the software tool based on artificial intelligence.
- Who it may be relevant to
- Registry conditions: Diabetic Retinopathy (DR). Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preliminary Assessment of iCare RETCAD as an Automated Tool for Diabetic Retinopathy Screening
Overview
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.
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
Primary outcome measures
- 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 outcome measures (1)
- percentage of eyes for which the AI-based automatic tool produced a result [Time frame: 1-day visit]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07404657 · RETCAD-PVAL