Assessment of EyeArt Performance With Retinal Cameras

Diabetic Retinopathy Clinical Trial

Official title:

Assessment of EyeArt Performance With Retinal Cameras

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04984200
• Other study ID #: EN-01b
• Status: Completed
• Start date: July 13, 2021
• Est. completion date: August 19, 2022

Study information

• Verified date: November 2022
• Source: Eyenuk, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using retinal cameras and operators.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: August 19, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy

Intervention

Procedure:
• Retinal imaging
Subjects will undergo retinal imaging before and/or after administration of mydriatic agent

Drug:
• Mydriatic Agent
Subjects will be administered mydriatic medication to dilate their pupils.

Locations

Country	Name	City	State
United States	Rocky Mountain Diabetes Center	Idaho Falls	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
Eyenuk, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall agreement between the results from multiple EyeArt operations	Overall agreement is defined as the fraction of cases where the multiple EyeArt operation results agree with each other.	1 visit (1 day)