Assessment of Retinal Fundus Imaging Camera

Status unconfirmed

Conditions studied: Diabetic Retinopathy, Diabetic Macular Edema

In brief

The goal of this prospective study is to evaluate device performance when using fundus images taken from retinal fundus cameras in subjects with and without diabetic retinopathy per ETDRS level 35 and higher with or without macular edema.

Key facts

Study ID

NCT06173232

Run by

Digital Diagnostics, Inc.

People needed

100

Starts

2023-11-20

Expected to finish

2024-05-01

Last updated by the study team

2023-12-15

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 the World Health Organization (WHO) and/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 75g 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.
• Diagnosis from a retinal specialist of ETDRS level of 35 or higher with or without DME or diagnosis from a retinal specialist of ETDRS level 20 or lower and no DME.
• Standard Corrected Visual Acuity of at least 20/40 or better in both eyes.

You may not qualify if…

• Currently participating in an interventional eye study (e.g., actively receiving the investigational product for Diabetic Retinopathy (DR) and/or Diabetic Macular Edema (DME)).
• Has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia, or previous enucleation).
• Pregnancy
• Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops.
• Any condition that is contraindicated for the use of study devices in the opinion of the investigator.
• 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

• Midwest Eye Center — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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