Status:
COMPLETED
Validation Study of RETINA-AI Galaxy™ v2.0, an Automated Diabetic Retinopathy Screening Device
Lead Sponsor:
RETINA-AI Health, Inc.
Conditions:
Diabetes
Diabetic Retinopathy
Eligibility:
All Genders
22+ years
Brief Summary
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 ha...
Detailed Description
This study was a prospective, multicenter, observational study to assess the safety and efficacy of the RETINA-AI Galaxy™ v2.0 ("Galaxy™") in screening for diabetic retinopathy in the primary care set...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Patient age 22 or above
- 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).
- Understanding of the Study and willingness and ability to sign informed consent
- EXCLUSION CRITERIA:
- Persistent vision loss in one or both eyes
- Diagnosis with macular edema, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, radiation retinopathy, or retinal vein occlusion.
- History of retinal laser treatment, or injections into either eye, or any history of retinal surgery.
- 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).
- Subject has contraindication to mydriatic agent (dilating drops) or is unwilling or unable to dilate.
- Subject is contraindicated from fundus photography (e.g. subject is hypersensitive to light).
Exclusion
Key Trial Info
Start Date :
November 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT05368623
Start Date
November 3 2022
End Date
March 31 2023
Last Update
October 16 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Organization
Los Angeles, California, United States, 92844
2
Clinical Research Organization
Chicago, Illinois, United States, 60402
3
Clinical Research Organization
Houston, Texas, United States, 77074