Assessment of Retinal Fundus Imaging Camera

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Retinopathy; Diabetic Macular Edema
• Intervention / Treatment: Device: Camera Imaging

Detailed Description

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 (ETDRS level 35 and higher) with or without macular edema. Study subjects will sign the informed consent form, and data collection will involve being imaged by cameras.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Breanne MacMillan, MS; Phone Number: 815-931-1354; Email: macmillan@digitaldiagnostics.com

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45202
      • Recruiting
      • Midwest Eye Center
      • Contact: Savannah Hollingsworth
      • Principal Investigator: Christopher Devine, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A minimum of 80 eligible subjects, these subjects will be categorized as ETDRS ≥ 35 with or without DME and subjects with ETDRS 20 or less and no DME

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Subjects with ETDRS ≥ 35 with or without DME	Device: Camera Imaging; Camera Imaging
Group 2; Subjects with ETDRS 20 or less and no DME	Device: Camera Imaging; Camera Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective	Agreement of AI device results (mtmDR(+), mtmDR(-)) obtained from fundus cameras	1 Day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Objective	Agreement of AI device probability scores obtained from fundus cameras	1 Day
Exploratory Endpoint	Agreement of AI device results (mtmDR(+), mtmDR(-), "Exam Quality Insufficient" obtained from fundus cameras	1 Day

Collaborators and Investigators

• Sponsor: Digital Diagnostics, Inc.
• Investigators: Study Director: Audrey Singh, BS, Digital Diagnostics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Diabetic Retinopathy; Macular Edema
• Other Study ID Numbers: PRO-CLN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No