Assessment of Retinal Fundus Imaging Camera

NCT06173232 | Unknown FDA Device

• 1 other identifier: PRO-CLN-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Retinopathy; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  Agreement of AI device results (mtmDR(+), mtmDR(-)) obtained from fundus cameras

  1 Day

Other Outcomes (2)

• Exploratory Objective

  1 Day

• Exploratory Endpoint

  1 Day

Study Arms (2)

Group 1

Subjects with ETDRS ≥ 35 with or without DME

Device: Camera Imaging

Group 2

Subjects with ETDRS 20 or less and no DME

Device: Camera Imaging

Interventions

Camera Imaging DEVICE

Camera Imaging

Group 1; Group 2

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Digital Diagnostics, Inc.: lead

Study Sites (1)

Midwest Eye Center

Cincinnati, Ohio, 45202, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Radionuclide Imaging

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Officials

• Audrey Singh, BS

  Digital Diagnostics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Breanne MacMillan, MS

CONTACT

815-931-1354; macmillan@digitaldiagnostics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: November 20, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)