Clareo Health | Efficacy and Safety of AEYE Diagnostic Screening (AEYE-DS) Software Device for Detection of Diabetic Retinopathy From Digital Funduscopic Images
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AEYE Health Inc
With
A. Stein Regulatory Affairs Consulting Ltd.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female, Age≥22
Documented diagnosis of diabetes mellitus, meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO):
1. Elevated Hemoglobin A1c (HbA1c) ≥ 6.5% (48mmol/mol), based on repeated assessments, performed in a laboratory using a method that is National Glycohemoglobin Standardization Program (NGSP) certified and standardized to the Diabetes Control and Complications Trial (DCCT) assay OR
2. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L), based on repeated assessments, where \'fasting\' is defined as no caloric intake for at least 8 hours OR
3. 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 OR
4. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dl (11.1 mmol/L)
Understand the study and volunteer to sign the informed consent
You may not be if
Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
Previously diagnosed with Diabetic Retinopathy.
History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
Currently participating in another investigational eye study and actively receiving investigational product for DR or Diabetic Macular Edema (DME).
Subject has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).
Subject is contraindicated for imaging by fundus imaging systems used in the study:
