OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastro SB, Chula Vista, California, United States

About this study

This study will be conducted to assess the feasibility of the OPTDR01 in detecting mtmDR and vtDR in frontline care settings in adults with a diagnosis of diabetes but no prior diagnosis of diabetic retinopathy. The study will inform the design of a large pivotal study in terms of expected disease prevalence, participant recruitment rate, data collection tools and study workflow.

Eligible participants will undergo the following:

retinal imaging sessions of each eye with a fundus camera for OPTDR01 evaluation
dilation with mydriatic agent
fundus photography, macular optical coherence tomography (OCT) and red reflex exam of each eye for comparison.

A subset of participants will be invited to participate in a precision sub-study, during which multiple operators will image participant eyes with multiple cameras.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Unable to understand the study
Unwilling to sign informed consent
Indicate persistent vision loss, blurred vision, or floaters
Previous diagnosis of macular edema, diabetic retinopathy (any level) proliferative retinopathy, radiation retinopathy, or retinal vein occlusion
History of laser treatment of the retina or injections into either eye, or any history of retinal surgery
Currently participating in another investigational eye study or actively receiving investigational product for diabetic retinopathy or diabetic macular edema
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
Known pregnancy

Treatment and study plan

OPTDR01 software application

Device

Retinal images will be sent to the OPTDR01 software application for mtmDR and vtDR detection

Primary outcomes

Enrollment rate of eligible participants at clinical site

Time frame: Assessed weekly until study end

Number of eligible participants that are enrolled on a weekly basis at a clinical site

Sponsors and collaborators

Lead sponsor

Optain Health

Industry

Collaborators

Global BioClinical

Registry information

Official study title

Prospective Pilot Study to Assess the Usability and Feasibility of OPTDR01 as an Automated Diabetic Retinopathy Screening Tool

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Apr 2, 2024
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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