ARDA Software for the Detection of mtmDR

A Multicenter Study to Evaluate the Performance of Automated Retinal Disease Assessment Software for the Detection of More Than Mild Diabetic Retinopathy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04905459

Enrollment

1012

Registered

2021-05-27

Start date

2021-09-30

Completion date

2022-05-23

Last updated

2022-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Brief summary

This is a multicenter, observational study with primary endpoints to determine the sensitivity and specificity of two investigational software devices that detect the presence of more than mild diabetic retinopathy (mtmDR) in healthcare settings.

Interventions

DIAGNOSTIC_TESTARDA software application

Subject images will be sent to the investigational ARDA software

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Documented diagnosis of Type I or Type II diabetes mellitus: meet the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA) 2. Age 22 or older 3. Understand the study and volunteer to sign the informed consent

Exclusion criteria

1. Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses). 2. Diagnosed with macular edema, any known retinopathy, radiation retinopathy, or retinal vein occlusion. 3. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery. 4. Scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy. 5. Currently participating in an interventional study. 6. Participant 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, etc.). 7. Participant is contraindicated for imaging by fundus imaging system used in the study; e.g. 1. Participant is hypersensitive to light (side effect of medication or due to unknown etiology) 2. Participant has undergone photodynamic therapy (PDT) 3. Previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops). 8. Known pregnancy or possibility of pregnancy

Design outcomes

Primary

Measure	Time frame
Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images	1 day
Specificity of ARDA mtmDR for detection of mtmDR in 45 degree images	1 day
Sensitivity of ARDA mtmDR for detection of mtmDR in UWF images	1 day
Specificity of ARDA mtmDR for detection of mtmDR in UWF images	1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026