CClinicalTrials.gg
CompletedNCT04984200Updated Nov 9, 2022

Assessment of EyeArt Performance With Retinal Cameras

An observational study in Diabetic Retinopathy, sponsored by Eyenuk, Inc.. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2022-11-09.

Sponsored by Eyenuk, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
246
Ages
22 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetic Retinopathy

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03

In context

Diabetic Retinopathy

773 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.

This study's enrollment of 246 is above the median of 154 across 264 observational studies indexed under Diabetic Retinopathy.

Browse Diabetic Retinopathy studies →

Lead sponsor

Eyenuk, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
246 participants (actual)
Patient registry
No

Groups and cohorts

  • AB

    Procedure: Retinal imaging · Drug: Mydriatic Agent

Interventions

  • ProcedureRetinal imaging

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

  • DrugMydriatic Agent

    Subjects will be administered mydriatic medication to dilate their pupils.

06

What researchers measure

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.

    Time frame: 1 visit (1 day)

07

Study locations

1 site
  • Rocky Mountain Diabetes Center
    Idaho Falls, Idaho 83404, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04984200
Lead sponsor
Eyenuk, Inc.
Responsible party
Sponsor
First posted
Jul 30, 2021
Start date
Jul 13, 2021
Primary completion
Aug 19, 2022
Completion
Aug 19, 2022
Last update
Nov 9, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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