Recruiting

Observational Study

Sponsor:

Digital Diagnostics, Inc.

Code:

NCT06173232

Conditions

Diabetic Retinopathy

Diabetic Macular Edema

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Camera Imaging

Study Details

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

Study ID

NCT06173232

Start date

Nov 20, 2023

Status verified date

Dec, 2023

Completion date

May, 2024

Anticipated

Primary completion date

Mar, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

Subjects with ETDRS ≥ 35 with or without DME

Group 2

Subjects with ETDRS 20 or less and no DME

Interventions

Camera Imaging

Camera Imaging

Primary outcome measure

  • Primary Objective [ Time Frame: 1 Day ]

Central Contacts and Locations

Central contacts

Breanne MacMillan, MS

815-931-1354macmillan@digitaldiagnostics.com

Locations

Midwest Eye Center

Recruiting

Cincinnati, Ohio, United States, 45202

Principal Investigator:

Christopher Devine, MD

More Information

Sponsor

Digital Diagnostics, Inc.

Last update posted

Dec 15, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Digital Diagnostics, Inc. on 2023-12-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.