Assessment of EyeArt Performance With Retinal Cameras

NCT04984200 | Completed FDA Device

• 1 other identifier: EN-01b
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

AB

Procedure: Retinal imaging; Drug: Mydriatic Agent

Interventions

Retinal imaging PROCEDURE

Subjects will undergo retinal imaging before and/or after administration of mydriatic agent

AB

Mydriatic Agent DRUG

Subjects will be administered mydriatic medication to dilate their pupils.

AB

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects will be enrolled at primary care and/or eye care centers

You may qualify if:

• A diagnosis of diabetes mellitus;
• Understanding of study and provision of written informed consent; and
• years of age or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eyenuk, Inc.: lead

Study Sites (1)

Rocky Mountain Diabetes Center

Idaho Falls, Idaho, 83404, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Mydriatics

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 30, 2021
• Study Start: July 13, 2021
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

US (1)