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Clinical trial

Assessment of EyeArt Performance With Retinal Cameras

ID
Name
EN-01b
Description
The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using retinal cameras and operators.
Trial arms
Trial start
2021-07-13
Estimated PCD
2022-08-19
Trial end
2022-08-19
Status
Completed
Treatment
Retinal imaging
Subjects will undergo retinal imaging before and/or after administration of mydriatic agent
Arms:
AB
Mydriatic Agent
Subjects will be administered mydriatic medication to dilate their pupils.
Arms:
AB
Size
246
Primary endpoint
Overall agreement between the results from multiple EyeArt operations
1 visit (1 day)
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'count': 246, 'type': 'ACTUAL'}}
Updated at
2022-11-09

1 organization

1 product

1 indication

Organization
Eyenuk
Product
Mydriatic Agent
Indication
Diabetic Retinopathy