NW500 Non-Mydriatic Retinal Camera Clinical Performance S... | NCT05286502

Studies
NW500 Non-Mydriatic Retinal Camera Clinical Performance Study

NCT05286502

Sponsor

Topcon Corporation

Status

Completed

Last Update Posted

Jun 8, 2022Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Fundus Photography

Interventions

fundus photography

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

Mar 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

Mar 1, 2022Actual

Primary Completion Date

Mar 1, 2022Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Feb 28, 2022

First Submission Date that Met QC Criteria

Mar 17, 2022

First Posted Date

Mar 18, 2022Actual

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

Jun 6, 2022

Last Update Posted Date

Jun 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparison of color fundus images acquired by the Topcon NW500 non-mydriatic retinal camera (investigational device) and the Topcon TRC-NW400 (predicate device)

Detailed Description

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adults 18 years old or older			Device: fundus photography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fundus photography	Device	color fundus photography	Adults 18 years old or older

Measure	Description	Time Frame
fundus photo image quality		1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who are 18 years of age or older on the date of informed consent.
Subjects who are able to understand the written informed consent and are willing to participate as evidenced by signing the informed consent.

Exclusion Criteria:

Subjects who are unable to tolerate ophthalmic imaging.
Subjects with poor fixation or ocular media not sufficiently clear to obtain acceptable images.
Subjects who cannot follow instructions to complete the required testing.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects 18 years old or older.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Topcon Healthcare Solutions		Oakland	New Jersey	07436	United States

Intervention Browse Module

MeSH Terms

ID	Term
D005451	Fluorescein Angiography

Ancestor Terms

ID	Term
D000792	Angiography
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided