Camera Qualification Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
A multi-center Study to demonstrate substantial equivalence of automated device detecting diabetic retinopathy using a handheld fundus camera with IDx-DR.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Fundus camera image Subjects imaged with a fundus camera |
Device: handheld fundus camera
Fundus camera
|
Outcome Measures
Primary Outcome Measures
- Sensitivity and Specificity Corrected for Enrichment [Day 1]
Estimation sensitivity and specificity corrected for enrichment using logistic regression, Level 1
Secondary Outcome Measures
- Observed Sensitivity and Specificity, Level II [Day 1]
Estimation diagnosability, and observed sensitivity and specificity
Other Outcome Measures
- Precision substudy [~1-month after Day 1]
Evaluate the repeatability and reproducibility of IDx-DR with camera
Eligibility Criteria
Criteria
Inclusion Criteria:
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22 years of age or older
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Documented diagnosis of diabetes mellitus, as per any of the following:
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Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
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Hemoglobin A1c (HbA1c) ≥ 6.5%
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Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
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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
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Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
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Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
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Currently participating in an interventional eye study
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Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops
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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)
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Pregnancy
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Self-report of visual symptoms including vision loss or blurred vision that cannot be corrected (e.g., with eyeglasses) or floaters
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History of laser treatment of the retina, injections into either eye, or any history of retinal surgery
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Previous confirmed diagnosis of a retinal disease (e.g., macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion)
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Any condition that is contraindicated for the use of the study camera
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Contraindication for imaging by devices used in the study due to any of the following:
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Subject is hypersensitive to light
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Subject recently underwent photodynamic therapy (PDT)
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Subject is taking medication that causes photosensitivity
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Infinity Clinical Research | Norco | California | United States | 92860 |
| 2 | Dream Team | Pomona | California | United States | 91767 |
| 3 | East Cost Institute for Research | Jacksonville | Florida | United States | 32216 |
| 4 | Olive Branch Family Medical Center | Olive Branch | Mississippi | United States | 38654 |
| 5 | Logan Health | Kalispell | Montana | United States | 59901 |
| 6 | Allure Health | Friendswood | Texas | United States | 77546 |
| 7 | Mt. Olympus Medical Research | Sugar Land | Texas | United States | 77479 |
Sponsors and Collaborators
- Digital Diagnostics, Inc.
- Laboratory Corporation of America
Investigators
- Study Chair: Michael Abramnoff, MD, PhD, Digital Diagnostics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DXSDR006