Diabetic Retinopathy (DR)NCT07404657
Preliminary Assessment of an Automated Tool for Diabetic Retinopathy Screening
An observational study of Diabetic Retinopathy (DR), run by Centervue SpA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetic Retinopathy (DR)
- What is being tested?
- automatic analysis of fundus images performed by the software tool based on artificial intelligence
- Type of treatment
- Medical device
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2026to 17 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: population attending a primary-care facility with diagnosis of diabetes mellitus and/or past diagnosis of diabetic retinopathy
Who may be able to join
- 22 years old or older
- diabetes or diabetic retinopathy
- understand the study information and able to sign a consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rovia University - Jacksonville (East Coast for Institute Jacksonville)
Jacksonville, Florida, 32216
About this study
Official title: 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.
- Conditions
- Diabetic Retinopathy (DR)
- Being tested
- automatic analysis of fundus images performed by the software tool based on artificial intelligence
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automatic analysis of fundus images performed by the software tool based on artificial intelligenceDevice
the duration of the intervention is the analysis performed by the software tool based on fundus images acquired
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1-day visit
Secondary outcomes (1)
percentage of eyes for which the AI-based automatic tool produced a result
Measured: 1-day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start6 Feb 2026
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy (DR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centervue SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404657
- Sponsor's protocol ID
- RETCAD-PVAL
- Status last verified
- Oct 2026
- First submitted
- 5 Feb 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Assessment of iCare RETCAD as an Automated Tool for Diabetic Retinopathy Screening
- ClinicalTrials.gov ID
- NCT07404657
- Acronym / sponsor ID
- RETCAD-PVAL
- Conditions
- Diabetic Retinopathy (DR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Centervue SpAIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- population attending a primary-care facility with diagnosis of diabetes mellitus and/or past diagnosis of diabetic retinopathy
Key inclusion criteria (3 listed)
- 22 years old or older
- diabetes or diabetic retinopathy
- understand the study information and able to sign a consent form
Key exclusion criteria (7 listed)
- cannot tolerate eye imaging tests
- laser treatment or injections
- eye surgery, except for simple cataract surgery
- currently involved in another study
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| automatic analysis of fundus images performed by the software tool based on artificial intelligencethe duration of the intervention is the analysis performed by the software tool based on fundus images acquired | Device | – |
Primary outcome
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 secondary outcome
percentage of eyes for which the AI-based automatic tool produced a result
Time frame: 1-day visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy (DR), run by Centervue SpA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.