Camera Qualification Study

Digital Diagnostics

Status: Active, not recruiting

Conditions: Diabetic Retinopathy

Treatments: Device: handheld fundus camera

Study type: Observational

Funder types: Industry

Identifiers

NCT05808699

DXSDR006

Details and patient eligibility

About

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.

Full description

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

Enrollment: 626 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

626 participants in 1 patient group

Fundus camera image

Description:

Subjects imaged with a fundus camera

Treatment:

Device: handheld fundus camera