NCT06343350Completed
OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection
Prospective Pilot Study to Assess the Usability and Feasibility of OPTDR01 as an Automated Diabetic Retinopathy Screening Tool
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
In the United States, only 62% of the 37 million people with diabetes receive annual screening exams for diabetic retinopathy. One of the goals of the US Department of Health and Human Services Healthy People 2030 campaign is to increase diabetic retinopathy screening rates to 70.3%. Research indicates that low screening rates are associated with a variety of factors, including income levels, race and lack of access to care. Furthermore, because diabetic retinopathy frequently presents asymptomatically, non-adherence to screening results in postponed disease detection and a higher probability of vision loss. Currently, it is estimated that 9 million adults in the US are affected by diabetic retinopathy, and 1.8 million suffer from vision-threatening diabetic retinopathy. Importantly, the rates of vtDR vary greatly by race, with Hispanic individuals at 7.14% and Black individuals at 8.66%, compared to 3.55% in White individuals. Despite these alarming figures, the disease can be managed and vision loss can often be averted with early disease detection, thus highlighting the importance of increasing screening rates. A clear need exists for a diabetic retinopathy screening tool that can be deployed in primary care settings, addressing the shortage of specialist care and making screening more accessible to underserved populations. OPTDR01 will directly address these issues by providing accessible, high quality screening for diabetic retinopathy. OPTDR01 will automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in diabetic adults who have not previously been diagnosed with mtmDR or vtDR.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 300 (actual)
- First submitted
- 25 Mar 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 6 Oct 2025
- Lead sponsor
- Optain Health
- Diseases
- Diabetic eye disease
- NCT number
- NCT06343350
What you commit to
- Study type: Observational
- Participants enrolled: 300
- From 1 Apr 2024 to the primary completion date, 6 Oct 2025
- 3 sites 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
- Previous diagnosis of macular edema, diabetic retinopathy (any level) proliferative retinopathy, radiation retinopathy, or retinal vein occlusion
- Currently participating in another investigational eye study or actively receiving investigational product for diabetic retinopathy or diabetic macular edema
Other illness
- History of laser treatment of the retina or injections into either eye, or any history of retinal surgery
- A condition that, in the opinion of the investigator, would preclude participation in the study
- 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
Other
- Unable to understand the study
- Unwilling to sign informed consent
- Indicate persistent vision loss, blurred vision, or floaters
- Known pregnancy
Who the study is looking for
- Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA):
- Age 22 or older
- Understand the study and volunteer to sign the informed consent
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gastro SB Coordinator of this site? Confirm its status | Chula Vista | United States | Unknown status |
| Gulf Coast Clinical Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Triwest Research Associates Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.