Assessment of EyeArt Performance With Retinal Cameras | NCT04984200

Studies
Assessment of EyeArt Performance With Retinal Cameras

NCT04984200

Sponsor

Eyenuk, Inc.

Status

Completed

Last Update Posted

Nov 9, 2022Actual

Enrollment

246Actual

Phase

Not provided

Conditions

Diabetic Retinopathy

Interventions

Retinal imaging
Mydriatic Agent

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 13, 2021Actual

Primary Completion Date

Aug 19, 2022Actual

Completion Date

Aug 19, 2022Actual

First Submitted Date

Jul 16, 2021

First Submission Date that Met QC Criteria

Jul 20, 2021

First Posted Date

Jul 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2022

Last Update Posted Date

Nov 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

246Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AB			Procedure: Retinal imaging Drug: Mydriatic Agent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Retinal imaging	Procedure	Subjects will undergo retinal imaging before and/or after administration of mydriatic agent	AB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Rocky Mountain Diabetes Center		Idaho Falls	Idaho	83404	United States

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009184	Mydriatics

Ancestor Terms

ID	Term
D001337	Autonomic Agents
D018373	Peripheral Nervous System Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided