Camera Qualification Study

Active, not recruiting

• Conditions: Diabetic Retinopathy
• Interventions: Device: handheld fundus camera

• Registration Number: NCT05808699
• Lead Sponsor: Digital Diagnostics, Inc.

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.

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 Timeline

• Study Start: 2023-03-03
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-04-11
• Primary Completion: 2023-11-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 626

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fundus camera image	handheld fundus camera	Subjects imaged with a fundus camera

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity Corrected for Enrichment	Day 1	Estimation sensitivity and specificity corrected for enrichment using logistic regression, Level 1

Secondary Outcome Measures

Name	Time	Method
Observed Sensitivity and Specificity, Level II	Day 1	Estimation diagnosability, and observed sensitivity and specificity

Trial Locations

Locations (9)

Ocean Wellness Center; 🇺🇸 Miami Gardens, Florida, United States

Infinity Clinical Research; 🇺🇸 Norco, California, United States

Dream Team; 🇺🇸 Pomona, California, United States

East Cost Institute for Research; 🇺🇸 Jacksonville, Florida, United States

Logan Health; 🇺🇸 Kalispell, Montana, United States

Allure Health; 🇺🇸 Friendswood, Texas, United States

Olive Branch Family Medical Center; 🇺🇸 Olive Branch, Mississippi, United States

Lillestol Research, LLC; 🇺🇸 Fargo, North Dakota, United States

Mt. Olympus Medical Research; 🇺🇸 Sugar Land, Texas, United States