Diabetic Retinopathy
Conditions
Brief summary
The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using multiple retinal imaging devices and operators.
Interventions
PROCEDUREColor fundus photography
Subjects will undergo fundus photography before and/or after administration of mydriatic agent
DRUGMydriatic Agent
Subjects may be administered mydriatic medication to dilate their pupils.
Sponsors
Eyenuk, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of diabetes mellitus; * Understanding of study and provision of written informed consent; and * 22 years of age or older.
Exclusion criteria
* Persistent visual impairment in one or both eyes; * History of macular edema, severe non-proliferative retinopathy, proliferative retinopathy, or retinal vascular (vein or artery) occlusion; * History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications; * Subject is contraindicated for fundus photography (for example, has light sensitivity); * Subject has contraindications for mydriatic medications or is unwilling or unable to dilate; * Subject is currently enrolled in an interventional study of an investigational device or drug; or * Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable dilated fundus photographs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Agreement between multiple EyeArt operations | 1 visit (1 day) |
Countries
United States
Outcome results
None listed