Diabetic Retinopathy
Conditions
Brief summary
The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using retinal cameras and operators.
Interventions
PROCEDURERetinal imaging
Subjects will undergo retinal imaging before and/or after administration of mydriatic agent
DRUGMydriatic Agent
Subjects will 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 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 | Description |
|---|---|---|
| Overall agreement between the results from multiple EyeArt operations | 1 visit (1 day) | Overall agreement is defined as the fraction of cases where the multiple EyeArt operation results agree with each other. |
Countries
United States
Outcome results
None listed