Camera Qualification Study

Camera Qualification of an Additional Fundus Camera Paired With An Autonomous AI for Detecting Diabetic Retinopathy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Device: handheld fundus camera

Detailed Description

A multi-center Study to demonstrate non-inferiority of the automated device detecting diabetic retinopathy using a handheld fundus camera with IDx-DR.

• Study Type: Observational
• Enrollment (Actual): 626

Contacts and Locations

Study Locations

• United States
  • California
    • Norco, California, United States, 92860
      • Infinity Clinical Research
    • Pomona, California, United States, 91767
      • Dream Team
  • Florida
    • Jacksonville, Florida, United States, 32216
      • East Cost Institute for Research
    • Miami Gardens, Florida, United States, 33169
      • Ocean Wellness Center
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Olive Branch Family Medical Center
  • Montana
    • Kalispell, Montana, United States, 59901
      • Logan Health
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research, LLC
  • Texas
    • Friendswood, Texas, United States, 77546
      • Allure Health
    • Sugar Land, Texas, United States, 77479
      • Mt. Olympus Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic - sampling method: non-probability sequential, invitation to volunteer

Description

Inclusion Criteria:

1. 22 years of age or older

2. Documented diagnosis of diabetes mellitus, as per any of the following:

   1. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
   2. Hemoglobin A1c (HbA1c) ≥ 6.5%
   3. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
   4. 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
   5. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
3. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Currently participating in an interventional eye study
2. Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops
3. 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)
4. Pregnancy
5. Self-report of visual symptoms including vision loss or blurred vision that cannot be corrected (e.g., with eyeglasses) or floaters
6. History of laser treatment of the retina, injections into either eye, or any history of retinal surgery
7. Previous confirmed diagnosis of a retinal disease (e.g., macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion)
8. Any condition that is contraindicated for the use of the study camera

9. Contraindication for imaging by devices used in the study due to any of the following:

   1. Subject is hypersensitive to light
   2. Subject recently underwent photodynamic therapy (PDT)
   3. Subject is taking medication that causes photosensitivity

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fundus camera image; Subjects imaged with a fundus camera	Device: handheld fundus camera; Fundus camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity Corrected for Enrichment	Estimation sensitivity and specificity corrected for enrichment using logistic regression, Level 1	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observed Sensitivity and Specificity, Level II	Estimation diagnosability, and observed sensitivity and specificity	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Precision substudy	Evaluate the repeatability and reproducibility of IDx-DR with the camera in protocol DXSDR006. Additionally, another IRB-approved R&R study (i.e., similar to DXSDR006 precision substudy) was conducted to evaluate parameters that may optimize R&R outcomes.	~1-month after Day 1

Collaborators and Investigators

• Sponsor: Digital Diagnostics, Inc.
• Collaborators: Laboratory Corporation of America
• Investigators: Study Chair: Michael Abramnoff, MD, PhD, Digital Diagnostics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: DXSDR006

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