NCT07844317Recruiting
Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy
A Multicenter, Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Automated System for Detecting Diabetic Retinopathy Using a Fundus Camera
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 14 Sept 2026
- Start date
- 24 Aug 2026
- Primary completion date
- 30 May 2027
- Lead sponsor
- Digital Diagnostics, Inc.
- Diseases
- Diabetic eye disease
- NCT number
- NCT07844317
What you commit to
- Study type: Observational
- Planned participants: 800
- From 24 Aug 2026 to the primary completion date, 30 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants may be excluded if they have significant ocular conditions or prior ocular treatments that could interfere with retinal imaging or study assessments; are currently participating in another interventional ophthalmic clinical trial; have medical conditions that may affect study participation or data interpretation; are pregnant; or have contraindications to study-related imaging procedures.
Who the study is looking for
- 22 years of age or older
- Diagnosis of DM
- Ability to understand and willing to sign a written ICF
Age in the registry: 22 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rovia Site Network Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.