Assessment of EyeArt Performance With Retinal Cameras
Completed
- Conditions
- Diabetic Retinopathy
- Interventions
- Procedure: Retinal imagingDrug: Mydriatic Agent
- Registration Number
- NCT04984200
- Lead Sponsor
- Eyenuk, Inc.
- Brief Summary
The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using retinal cameras and operators.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 246
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AB Retinal imaging - AB Mydriatic Agent -
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rocky Mountain Diabetes Center
🇺🇸Idaho Falls, Idaho, United States