Camera Qualification Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

626 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-03

Study Completion Date

2025-01-30

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.

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Detailed Description

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A multi-center Study to demonstrate non-inferiority of the automated device detecting diabetic retinopathy using a handheld fundus camera with IDx-DR.

Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Fundus camera image

Subjects imaged with a fundus camera

handheld fundus camera

Intervention Type DEVICE

Fundus camera

Interventions

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handheld fundus camera

Fundus camera

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 22 years of age or older
2. Documented diagnosis of diabetes mellitus, as per any of the following:

1. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
2. Hemoglobin A1c (HbA1c) ≥ 6.5%
3. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
4. 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
5. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
3. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

1. Currently participating in an interventional eye study
2. Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops
3. 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)
4. Pregnancy
5. Self-report of visual symptoms including vision loss or blurred vision that cannot be corrected (e.g., with eyeglasses) or floaters
6. History of laser treatment of the retina, injections into either eye, or any history of retinal surgery
7. Previous confirmed diagnosis of a retinal disease (e.g., macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion)
8. Any condition that is contraindicated for the use of the study camera
9. Contraindication for imaging by devices used in the study due to any of the following:

1. Subject is hypersensitive to light
2. Subject recently underwent photodynamic therapy (PDT)
3. Subject is taking medication that causes photosensitivity

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No