Assessment of EyeArt Performance With Retinal Cameras

Eyenuk, Inc. (Industry)
Overall Status
Enrolling by invitation ID

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
  • Procedure: Retinal imaging
  • Drug: Mydriatic Agent

Study Design

Study Type:
Anticipated Enrollment :
168 participants
Observational Model:
Time Perspective:
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

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


Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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


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

Sponsors and Collaborators

  • Eyenuk, Inc.


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Eyenuk, Inc. Identifier:
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:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 30, 2021