NCT07844317 · Digital Diagnostics, Inc.
Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy
What this study is about
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.
View original scientific description
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.
Interventions
DEVICE
SaMD intended for the detection of diabetic retinopathy in adults with diabetes.
No significant difference to other SaMDs for the detection of DR that are commercialized.
DEVICE
An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes.
SaMD to detect diabetic retinopathy
Primary outcome measures
Evaluation of the safety and efficacy of an AI-based SaMD with a fundus camera for the detection of Diabetic Retinopathy
Time frame: 1-year
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Jacksonville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 28, 2026 · Source of record for eligibility and locations