RECRUITING

OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-01
Study Completion:2025-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06343350

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA):
  2. 2. Age 22 or older
  3. 3. Understand the study and volunteer to sign the informed consent
  1. 1. Unable to understand the study
  2. 2. Unwilling to sign informed consent
  3. 3. Indicate persistent vision loss, blurred vision, or floaters
  4. 4. Previous diagnosis of macular edema, diabetic retinopathy (any level) proliferative retinopathy, radiation retinopathy, or retinal vein occlusion
  5. 5. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery
  6. 6. Currently participating in another investigational eye study or actively receiving investigational product for diabetic retinopathy or diabetic macular edema
  7. 7. A condition that, in the opinion of the investigator, would preclude participation in the study
  8. 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. 9. Known pregnancy

Contacts and Locations

Study Contact

Alejandra Maciel
CONTACT
8585251789
alejandra@optainhealth.com

Study Locations (Sites)

Gastro SB
Chula Vista, California, 91910
United States
Triwest Research Associates
San Diego, California, 92108
United States
Precision Research Institute
San Diego, California, 92114
United States
Gulf Coast Clinical Research
Houston, Texas, 77070
United States

Collaborators and Investigators

Sponsor: Optain Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2025-01-30

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2025-01-30

Terms related to this study

Keywords Provided by Researchers

  • Artificial Intelligence
  • Diabetic Retinopathy
  • SaMD
  • Screening

Additional Relevant MeSH Terms

  • Diabetic Retinopathy
  • Diabetes