Camera Qualification Study

Study Overview
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Brief Summary
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A multi-center study to evaluate the performance of an automated device for the detection of diabetic retinopathy with the use of an additional fundus camera with IDx-DR.

Detailed Description
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A multi-center Study to demonstrate substantial equivalence of automated device detecting diabetic retinopathy using a handheld fundus camera with IDx-DR.

Official Title
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Camera Qualification of an Additional Fundus Camera Paired With An Autonomous AI for Detecting Diabetic Retinopathy

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Device: handheld fundus camera


Participation Criteria
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Eligibility Criteria
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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 either the World Health Organization (WHO) 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 75 g 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 Exclusion Criteria: Currently participating in an interventional eye study Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops Has a condition that, in the opinion of a licensed clinical team member or investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation) Pregnancy Self-report of visual symptoms including vision loss or blurred vision that cannot be corrected (e.g., with eyeglasses) or floaters History of laser treatment of the retina, injections into either eye, or any history of retinal surgery Previous confirmed diagnosis of a retinal disease (e.g., macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion) Any condition that is contraindicated for the use of the study camera 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

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 |
| --- | --- |
| Fundus camera image<br>Subjects imaged with a fundus camera | Device: handheld fundus camera<br>* Fundus camera<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity Corrected for Enrichment | Estimation sensitivity and specificity corrected for enrichment using logistic regression, Level 1 | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed Sensitivity and Specificity, Level II | Estimation diagnosability, and observed sensitivity and specificity | Day 1 |