Validation Study of RETINA-AI Galaxy™ v2.0, an Automated Diabetic Retinopathy Screening Device

RETINA-AI-CT2

Diabetes affects over 37 million Americans and over 530 million people globally. Each diabetic patient needs at least one retinal exam per year starting immediately at the time of diagnosis if they have Type II diabetes (and starting at 5th year after disease onset if they have Type I diabetes). However, majority of diabetic patients do not get their eye exam due to multiple prohibitive factors such as cost, transportation, difficulty of taking time off from work, and inconvenience, amongst others. As a result, diabetes is the most common cause of visual impairment and blindness in working age adults in the United States and globally. Early detection via effective screening can prevent diabetes-related blindness. However, there are multiple barriers to screening. This prompted the development of RETINA-AI Galaxy™ v2.0, an automated Software as a Medical Device that screens for diabetic retinopathy in the primary care setting. This observational study was designed to validate the safety and efficacy of the RETINA-AI Galaxy™ Software-as-a-Medical-Device.

2022-11-03

2023-03-31

2023-03-31

Completed

1100

INCLUSION CRITERIA 1. Patient age 22 or above 2. Patient with a documented diagnosis of diabetes as defined by any of the following: A. Hemoglobin A1c (HbA1c) ≥ 6.5% based on repeated assessments B. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) based on repeated assessments C. Oral Glucose Tolerance test with 2-hour plasma glucose ≥ 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water. D. Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose ≥ 200mg/dL (11.1 mmol/L) E. Criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA). 3. Understanding of the Study and willingness and ability to sign informed consent EXCLUSION CRITERIA: 1. Persistent vision loss in one or both eyes 2. Diagnosis with macular edema, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, radiation retinopathy, or retinal vein occlusion. 3. History of retinal laser treatment, or injections into either eye, or any history of retinal surgery. 4. Currently enrolled in another interventional study of an investigational device or drug and actively receiving an investigational product for diabetic retinopathy (DR) or Diabetic Macula Edema (DME). 5. Subject has contraindication to mydriatic agent (dilating drops) or is unwilling or unable to dilate. 6. Subject is contraindicated from fundus photography (e.g. subject is hypersensitive to light).

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'count': 1100, 'type': 'ACTUAL'}}

2023-10-16