Camera Qualification Study
Camera Qualification of an Additional Fundus Camera Paired With An Autonomous AI for Detecting Diabetic Retinopathy
1 other identifier
observational
626
1 country
9
Brief Summary
A multi-center study to evaluate the performance of an automated device for the detection of diabetic retinopathy with the use of an additional fundus camera with IDx-DR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2023
CompletedFirst Submitted
Initial submission to the registry
March 29, 2023
CompletedFirst Posted
Study publicly available on registry
April 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2025
CompletedOctober 22, 2024
October 1, 2024
9 months
March 29, 2023
October 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity Corrected for Enrichment
Estimation sensitivity and specificity corrected for enrichment using logistic regression, Level 1
Day 1
Secondary Outcomes (1)
Observed Sensitivity and Specificity, Level II
Day 1
Other Outcomes (1)
Precision substudy
~1-month after Day 1
Study Arms (1)
Fundus camera image
Subjects imaged with a fundus camera
Interventions
Eligibility Criteria
Primary care clinic - sampling method: non-probability sequential, invitation to volunteer
You may qualify if:
- years of age or older
- Documented diagnosis of diabetes mellitus, as per any of the following:
- Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
- Hemoglobin A1c (HbA1c) ≥ 6.5%
- Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
- Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) ≥ 200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water
- Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if:
- Currently participating in an interventional eye study
- Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops
- Has a condition that, in the opinion of a licensed clinical team member or investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation)
- Pregnancy
- Self-report of visual symptoms including vision loss or blurred vision that cannot be corrected (e.g., with eyeglasses) or floaters
- History of laser treatment of the retina, injections into either eye, or any history of retinal surgery
- Previous confirmed diagnosis of a retinal disease (e.g., macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion)
- Any condition that is contraindicated for the use of the study camera
- Contraindication for imaging by devices used in the study due to any of the following:
- Subject is hypersensitive to light
- Subject recently underwent photodynamic therapy (PDT)
- Subject is taking medication that causes photosensitivity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Digital Diagnostics, Inc.lead
- Laboratory Corporation of Americacollaborator
Study Sites (9)
Infinity Clinical Research
Norco, California, 92860, United States
Dream Team
Pomona, California, 91767, United States
East Cost Institute for Research
Jacksonville, Florida, 32216, United States
Ocean Wellness Center
Miami Gardens, Florida, 33169, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
Logan Health
Kalispell, Montana, 59901, United States
Lillestol Research, LLC
Fargo, North Dakota, 58104, United States
Allure Health
Friendswood, Texas, 77546, United States
Mt. Olympus Medical Research
Sugar Land, Texas, 77479, United States
Related Publications (1)
Abramoff MD, Lavin PT, Jakubowski JR, Blodi BA, Keeys M, Joyce C, Folk JC. Mitigation of AI adoption bias through an improved autonomous AI system for diabetic retinal disease. NPJ Digit Med. 2024 Dec 19;7(1):369. doi: 10.1038/s41746-024-01389-x.
PMID: 39702673DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Abramnoff, MD, PhD
Digital Diagnostics, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2023
First Posted
April 11, 2023
Study Start
March 3, 2023
Primary Completion
November 30, 2023
Study Completion
January 30, 2025
Last Updated
October 22, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share