Camera Qualification Study

Digital Diagnostics, Inc. (Industry)
Overall Status
Recruiting ID
Laboratory Corporation of America (Industry)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: handheld fundus camera

Detailed Description

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

Study Design

Study Type:
Anticipated Enrollment :
565 participants
Observational Model:
Time Perspective:
Official Title:
Camera Qualification of an Additional Fundus Camera Paired With An Autonomous AI for Detecting Diabetic Retinopathy
Actual Study Start Date :
Mar 3, 2023
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Fundus camera image

Subjects imaged with a fundus camera

Device: handheld fundus camera
Fundus camera

Outcome Measures

Primary Outcome Measures

  1. Sensitivity and Specificity Corrected for Enrichment [Day 1]

    Estimation sensitivity and specificity corrected for enrichment using logistic regression, Level 1

Secondary Outcome Measures

  1. Observed Sensitivity and Specificity, Level II [Day 1]

    Estimation diagnosability, and observed sensitivity and specificity

Other Outcome Measures

  1. Precision substudy [~1-month after Day 1]

    Evaluate the repeatability and reproducibility of IDx-DR with camera

Eligibility Criteria


Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  1. 22 years of age or older

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

  3. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)

  4. Hemoglobin A1c (HbA1c) ≥ 6.5%

  5. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)

  6. 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

  7. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)

  8. 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:

  10. Subject is hypersensitive to light

  11. Subject recently underwent photodynamic therapy (PDT)

  12. Subject is taking medication that causes photosensitivity

Contacts and Locations


Site City State Country Postal Code
1 Infinity Clinical Research Norco California United States 92860
2 Dream Team Pomona California United States 91767
3 East Cost Institute for Research Jacksonville Florida United States 32216
4 Olive Branch Family Medical Center Olive Branch Mississippi United States 38654
5 Logan Health Kalispell Montana United States 59901
6 Allure Health Friendswood Texas United States 77546
7 Mt. Olympus Medical Research Sugar Land Texas United States 77479

Sponsors and Collaborators

  • Digital Diagnostics, Inc.
  • Laboratory Corporation of America


  • Study Chair: Michael Abramnoff, MD, PhD, Digital Diagnostics, Inc.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Digital Diagnostics, Inc. Identifier:
Other Study ID Numbers:
  • DXSDR006
First Posted:
Apr 11, 2023
Last Update Posted:
Apr 13, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2023