Assessment of Retinal Fundus Imaging Camera

Diabetic Retinopathy Clinical Trial

Official title:

Assessment of Retinal Fundus Imaging Camera

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173232
• Other study ID #: PRO-CLN-001
• Status: Recruiting
• Start date: November 20, 2023
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: Digital Diagnostics, Inc.
• Contact: Breanne MacMillan, MS
• Phone: 815-931-1354
• Email: macmillan[@]digitaldiagnostics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Macular Edema

Intervention

Device:
• Camera Imaging
Camera Imaging

Locations

Country	Name	City	State
United States	Midwest Eye Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Digital Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Objective	Agreement of AI device probability scores obtained from fundus cameras	1 Day
Other	Exploratory Endpoint	Agreement of AI device results (mtmDR(+), mtmDR(-), "Exam Quality Insufficient" obtained from fundus cameras	1 Day
Primary	Primary Objective	Agreement of AI device results (mtmDR(+), mtmDR(-)) obtained from fundus cameras	1 Day