Assessment of EyeArt Performance With Retinal Cameras

• Sponsor: Eyenuk, Inc. (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04984200
• Collaborator: (none)
• Enrollment: 168
• Location: 1
• Anticipated Duration (Months): 2.6
• Patients Per Site Per Month: 64.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Procedure: Retinal imaging; Drug: Mydriatic Agent

Study Design

• Study Type: Observational
• Anticipated Enrollment: 168 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Assessment of EyeArt Performance With Retinal Cameras
• Actual Study Start Date: Jul 13, 2021
• Anticipated Primary Completion Date: Sep 30, 2021
• Anticipated Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
AB	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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rocky Mountain Diabetes Center	Idaho Falls	Idaho	United States	83404

Sponsors and Collaborators

• Eyenuk, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eyenuk, Inc.
• ClinicalTrials.gov Identifier: NCT04984200
• Other Study ID Numbers: EN-01b
• First Posted: Jul 30, 2021
• Last Update Posted: Jul 30, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Diabetic Retinopathy; Mydriatics

Study Results

No Results Posted as of Jul 30, 2021