OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection

April 1, 2024 updated by: Optain Health

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92114
        • Precision Research Institute
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Type I or Type II diabetes that are eligible for Diabetic Retinopathy screening

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retinal imaging
Participants will undergo retinal imaging with and without mydriatic agent to dilate the pupils.
Device: OPTDR01 software application
Retinal images will be sent to the OPTDR01 software application for mtmDR and vtDR detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed weekly until study end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTDR01P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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