NCT05808699Active, not recruitingNot Applicable
Camera Qualification of an Additional Fundus Camera Paired With An Autonomous AI for Detecting Diabetic Retinopathy
Digital Diagnostics, Inc.9 sites in 1 country626 target enrollmentStarted: March 3, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Digital Diagnostics, Inc.
- Enrollment
- 626
- Locations
- 9
- Primary Endpoint
- Sensitivity and Specificity Corrected for Enrichment
Study Overview
Brief Summary
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
A multi-center Study to demonstrate non-inferiority of the automated device detecting diabetic retinopathy using a handheld fundus camera with IDx-DR.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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
Outcomes
Primary Outcomes
Sensitivity and Specificity Corrected for Enrichment
Time Frame: Day 1
Estimation sensitivity and specificity corrected for enrichment using logistic regression, Level 1
Secondary Outcomes
- Observed Sensitivity and Specificity, Level II(Day 1)
Investigators
Study Sites (9)
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