Clinical trial NCT05808699: Camera Qualification Study
Official title: Camera Qualification of an Additional Fundus Camera Paired With An Autonomous AI for Detecting Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetic Retinopathy
Lead sponsor: Digital Diagnostics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Laboratory Corporation of America
First posted: 2023-04-11
Enrollment: 626
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic - sampling method: non-probability sequential, invitation to volunteer

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and Specificity Corrected for Enrichment
timeFrame: Day 1
Secondary outcomes:
measure: Observed Sensitivity and Specificity, Level II
timeFrame: Day 1
Other outcomes:
measure: Precision substudy
timeFrame: ~1-month after Day 1
Locations:
city: Norco
country: United States
facility: Infinity Clinical Research
state: California
city: Pomona
country: United States
facility: Dream Team
state: California
city: Jacksonville
country: United States
facility: East Cost Institute for Research
state: Florida
city: Miami Gardens
country: United States
facility: Ocean Wellness Center
state: Florida
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Kalispell
country: United States
facility: Logan Health
state: Montana
city: Fargo
country: United States
facility: Lillestol Research, LLC
state: North Dakota
city: Friendswood
country: United States
facility: Allure Health
state: Texas
city: Sugar Land
country: United States
facility: Mt. Olympus Medical Research
state: Texas
Study officials:
affiliation: Digital Diagnostics, Inc.
name: Michael Abramnoff, MD, PhD
role: STUDY_CHAIR
References: