Assessment of EyeArt Performance With Retinal Imaging Devices

Diabetic Retinopathy Clinical Trial

Official title:

Assessment of EyeArt Performance With Retinal Imaging Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302012
• Other study ID #: EN-01a
• Status: Completed
• Start date: December 18, 2019
• Est. completion date: February 27, 2020

Study information

• Verified date: July 2021
• 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 multiple retinal imaging devices and operators.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 27, 2020
• Est. primary completion date: February 27, 2020
• 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 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.

Related Conditions & MeSH terms

• Diabetic Retinopathy

Intervention

Procedure:
• Color fundus photography
Subjects will undergo fundus photography before and/or after administration of mydriatic agent

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

Locations

Country	Name	City	State
United States	Lundquist Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Eyenuk, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between multiple EyeArt operations		1 visit (1 day)