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
- Diabetic Retinopathy (DR)
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Digital Diagnostics, Inc.
- Enrolment target
- 800
- Started
- 24 August 2026
- Main results due
- 30 May 2027
- Study sites
- 1
- Registry updated
- 28 September 2026
Can you take part?
- Aged 22 years and over.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 22 years of age or older * Diagnosis of DM * Ability to understand and willing to sign a written ICF Exclusion Criteria: 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.
What this study is about
In the sponsor’s own words, from the registry.
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.
Study sites(1)
Rovia Site Network
Jacksonville, Florida, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07844317. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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