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Active, not recruitingNCT05808699Updated Oct 22, 2024

Camera Qualification Study

An observational study in Diabetic Retinopathy, sponsored by Digital Diagnostics, Inc.. Active, not recruiting at 9 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-10-22.

Sponsored by Digital Diagnostics, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
626
Ages
22 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Diabetic Retinopathy
03

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
626 participants (actual)
Patient registry
No

Groups and cohorts

  • Fundus camera image

    Subjects imaged with a fundus camera

    Device: handheld fundus camera

Interventions

  • Devicehandheld fundus camera

    Fundus camera

05

What researchers measure

Primary outcomes

  1. Sensitivity and Specificity Corrected for Enrichment

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

    Time frame: Day 1

Secondary outcomes

  1. Observed Sensitivity and Specificity, Level II

    Estimation diagnosability, and observed sensitivity and specificity

    Time frame: Day 1

Other outcomes

  1. 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.

    Time frame: ~1-month after Day 1

06

Study locations

9 sites
  • 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
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05808699
Lead sponsor
Digital Diagnostics, Inc.
Collaborators
Laboratory Corporation of America
Responsible party
Sponsor
First posted
Apr 11, 2023
Start date
Mar 3, 2023
Primary completion
Nov 30, 2023
Completion
Jan 30, 2025 (estimated)
Last update
Oct 22, 2024

Study contacts

Michael Abramnoff, MD, PhD
study chair · Digital Diagnostics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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