Automated detection of diabetic retinopathy using AI technology
Prospective Pilot Study to Assess the Usability and Feasibility of OPTDR01 As an Automated Diabetic Retinopathy Screening Tool
This study is testing a new AI tool to see if it can accurately find early signs of eye problems in adults with diabetes who haven't had any eye issues before.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Optain Health Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 4 sites (Chula Vista, California and 3 other locations) |
| Trial ID | NCT06343350 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of the OPTDR01 software application for detecting mild to moderate diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in adults diagnosed with diabetes but without prior diabetic retinopathy. Participants will undergo retinal imaging, including fundus photography and optical coherence tomography, to assess the effectiveness of the automated detection system. The findings will help inform the design of a larger pivotal study aimed at improving screening rates for diabetic retinopathy, particularly in underserved populations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 or older with a diagnosis of diabetes and no prior diagnosis of diabetic retinopathy.
Not a fit: Patients with a history of diabetic retinopathy or other significant retinal conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase the early detection of diabetic retinopathy, potentially reducing the risk of vision loss in patients with diabetes.
How similar studies have performed: Other studies utilizing AI for diabetic retinopathy detection have shown promising results, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA): 2. Age 22 or older 3. Understand the study and volunteer to sign the informed consent Exclusion Criteria: 1. Unable to understand the study 2. Unwilling to sign informed consent 3. Indicate persistent vision loss, blurred vision, or floaters 4. Previous diagnosis of macular edema, diabetic retinopathy (any level) proliferative retinopathy, radiation retinopathy, or retinal vein occlusion 5. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery 6. Currently participating in another investigational eye study or actively receiving investigational product for diabetic retinopathy or diabetic macular edema 7. A condition that, in the opinion of the investigator, would preclude participation in the study 8. Contraindicated for imaging by fundus imaging systems used in the study because of hypersensitivity to light, recently underwent photodynamic therapy, or was taking medication that causes photosensitivity 9. Known pregnancy
Where this trial is running
Chula Vista, California and 3 other locations
- Gastro SB — Chula Vista, California, United States (Recruiting)
- Triwest Research Associates — San Diego, California, United States (Recruiting)
- Precision Research Institute — San Diego, California, United States (Withdrawn)
- Gulf Coast Clinical Research — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Alejandra Maciel
- Email: alejandra@optainhealth.com
- Phone: 8585251789
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.