Assessment of EyeArt Performance With Retinal Cameras

November 7, 2022 updated by: Eyenuk, Inc.
The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using retinal cameras and operators.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

246

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AB
Drug: Mydriatic Agent
Subjects will be administered mydriatic medication to dilate their pupils.
Procedure: Retinal imaging
Subjects will undergo retinal imaging before and/or after administration of mydriatic agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall agreement between the results from multiple EyeArt operations
Time Frame: 1 visit (1 day)
Overall agreement is defined as the fraction of cases where the multiple EyeArt operation results agree with each other.
1 visit (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eyenuk, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2021

Primary Completion (Actual)

August 19, 2022

Study Completion (Actual)

August 19, 2022

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN-01b

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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