Evaluating a retinal imaging camera for diabetic eye conditions

Assessment of Retinal Fundus Imaging Camera

This study is testing a new retinal imaging camera to see how well it can take pictures of the eyes of people with and without diabetic eye conditions.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Digital Diagnostics, Inc. (industry)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT06173232 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the performance of a retinal fundus imaging camera in capturing images of subjects with and without diabetic retinopathy, specifically those classified at ETDRS level 35 and higher, with or without diabetic macular edema. Participants will be required to provide informed consent and will undergo imaging using the specified camera. The study focuses on understanding how effectively the device can capture relevant retinal images to aid in the diagnosis and management of diabetic eye diseases.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 22 and older with a documented diagnosis of diabetes and varying levels of diabetic retinopathy.

Not a fit: Patients who do not have diabetes or those with less severe forms of diabetic retinopathy (ETDRS level 20 or lower without DME) may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of diabetic retinopathy diagnosis and improve patient management strategies.

How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for diabetic retinopathy, suggesting that this approach may yield beneficial results.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Cincinnati, Ohio

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

Study contacts

• Study coordinator: Breanne MacMillan, MS

Conditions: Diabetic Retinopathy, Diabetic Macular Edema