Camera Qualification Study

Last updated: October 18, 2024
Sponsor: Digital Diagnostics, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetic Retinopathy

Retina

Treatment

handheld fundus camera

Clinical Study ID

NCT05808699
DXSDR006
  • Ages > 22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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) ≥ 200mg/dL (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucosedose 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 consentdocument

Exclusion

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 othermydriatic eye drops

  3. Has a condition that, in the opinion of a licensed clinical team member orinvestigator, would preclude participation in the study (e.g., unstable medicalstatus including blood pressure or glycemic control, microphthalmia or previousenucleation)

  4. Pregnancy

  5. Self-report of visual symptoms including vision loss or blurred vision that cannotbe corrected (e.g., with eyeglasses) or floaters

  6. History of laser treatment of the retina, injections into either eye, or any historyof retinal surgery

  7. Previous confirmed diagnosis of a retinal disease (e.g., macular edema, severenon-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, orretinal 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 thefollowing:

  10. Subject is hypersensitive to light

  11. Subject recently underwent photodynamic therapy (PDT)

  12. Subject is taking medication that causes photosensitivity

Study Design

Total Participants: 626
Treatment Group(s): 1
Primary Treatment: handheld fundus camera
Phase:
Study Start date:
March 03, 2023
Estimated Completion Date:
January 30, 2025

Study Description

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

Connect with a study center

  • Infinity Clinical Research

    Norco, California 92860
    United States

    Site Not Available

  • Dream Team

    Pomona, California 91767
    United States

    Site Not Available

  • East Cost Institute for Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Ocean Wellness Center

    Miami Gardens, Florida 33169
    United States

    Site Not Available

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi 38654
    United States

    Site Not Available

  • Logan Health

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Lillestol Research, LLC

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Allure Health

    Friendswood, Texas 77546
    United States

    Site Not Available

  • Mt. Olympus Medical Research

    Sugar Land, Texas 77479
    United States

    Site Not Available

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