ARDA Software for the Detection of mtmDR

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Diagnostic Test: ARDA software application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Age 22 or older Understand the study and volunteer to sign the informed consent Exclusion Criteria: Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses). Diagnosed with macular edema, any known retinopathy, radiation retinopathy, or retinal vein occlusion. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery. Scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy. Currently participating in an interventional study. 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.). Participant is contraindicated for imaging by fundus imaging system used in the study; e.g. Participant is hypersensitive to light (side effect of medication or due to unknown etiology) Participant has undergone photodynamic therapy (PDT) Previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops). Known pregnancy or possibility of pregnancy

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retinal Imaging and Mydriatic Agents<br>Subjects will undergo several types of retinal imaging before and after administration of mydriatic agent. Subjects will be administered mydriatic medication to dilate their pupils. | Diagnostic Test: ARDA software application<br>* Subject images will be sent to the investigational ARDA software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |