Camera Qualification Study

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05808699
• Other study ID #: DXSDR006
• Status: Active, not recruiting
• Start date: March 3, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2023
• Source: Digital Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 565
• Est. completion date: November 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Device:
• handheld fundus camera
Fundus camera

Locations

Country	Name	City	State
United States	Lillestol Research, LLC	Fargo	North Dakota
United States	Allure Health	Friendswood	Texas
United States	East Cost Institute for Research	Jacksonville	Florida
United States	Logan Health	Kalispell	Montana
United States	Infinity Clinical Research	Norco	California
United States	Olive Branch Family Medical Center	Olive Branch	Mississippi
United States	Dream Team	Pomona	California
United States	Mt. Olympus Medical Research	Sugar Land	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Digital Diagnostics, Inc.	Fortrea

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Precision substudy	Evaluate the repeatability and reproducibility of IDx-DR with camera	~1-month after Day 1
Primary	Sensitivity and Specificity Corrected for Enrichment	Estimation sensitivity and specificity corrected for enrichment using logistic regression, Level 1	Day 1
Secondary	Observed Sensitivity and Specificity, Level II	Estimation diagnosability, and observed sensitivity and specificity	Day 1