Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06173232
Other study ID # PRO-CLN-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT03660371 - ILM Peeling in PDR Patients Undergoing PPV for VH N/A
Completed NCT03660345 - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME Phase 3
Completed NCT03660384 - Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy N/A
Completed NCT04905459 - ARDA Software for the Detection of mtmDR
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT05022615 - Comparing 3 Imaging Systems
Completed NCT00385333 - Metabolic Mapping to Measure Retinal Metabolism Phase 2
Recruiting NCT04101604 - Biomarkers of Common Eye Diseases
Completed NCT03702374 - Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy Phase 3
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Completed NCT04009980 - Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus. N/A
Completed NCT02924311 - Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
Not yet recruiting NCT06257082 - Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities N/A
Not yet recruiting NCT05452993 - Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography N/A
Withdrawn NCT02812030 - Aflibercept for Retinopathy in the Real World N/A
Completed NCT02391558 - Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography N/A
Active, not recruiting NCT02330042 - OCT Biomarkers for Diabetic Retinopathy
Active, not recruiting NCT02353923 - OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy N/A
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A