Camera Qualification Study

Running, not enrolling

Conditions studied: Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT05808699

Run by

Digital Diagnostics, Inc.

People needed

626

Starts

2023-03-03

Expected to finish

2025-01-30

Last updated by the study team

2024-10-22

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 22 years of age or older
• Documented diagnosis of diabetes mellitus, as per any of the following:
• Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
• Hemoglobin A1c (HbA1c) ≥ 6.5%
• Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
• 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
• Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• Currently participating in an interventional eye study
• Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops
• 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)
• Pregnancy
• Self-report of visual symptoms including vision loss or blurred vision that cannot be corrected (e.g., with eyeglasses) or floaters
• History of laser treatment of the retina, injections into either eye, or any history of retinal surgery
• Previous confirmed diagnosis of a retinal disease (e.g., macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion)
• Any condition that is contraindicated for the use of the study camera
• Contraindication for imaging by devices used in the study due to any of the following:
• Subject is hypersensitive to light
• Subject recently underwent photodynamic therapy (PDT)
• Subject is taking medication that causes photosensitivity

Where it is running

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

Full record on ClinicalTrials.gov

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