Clinical Study of the Topcon Tonometer TRK-3 | NCT05167773

Studies
Clinical Study of the Topcon Tonometer TRK-3

NCT05167773

Sponsor

Topcon Corporation

Status

Completed

Last Update Posted

Jul 20, 2022Actual

Enrollment

139Actual

Phase

Not provided

Conditions

Intraocular Pressure

Interventions

tonometer

Countries

Japan

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

Jul 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

Oct 11, 2021Actual

Primary Completion Date

Jan 14, 2022Actual

Completion Date

Jan 14, 2022Actual

First Submitted Date

Nov 8, 2021

First Submission Date that Met QC Criteria

Dec 21, 2021

First Posted Date

Dec 22, 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

Jul 19, 2022

Last Update Posted Date

Jul 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will assess the TRK-3 for conformity to ISO 8612:2009, JIS T7312:2015, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and the applicable Supplemental Information Sheet.

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

139Actual

Name	Type	Description	Arm Group Labels	Other Names
tonometer	Device	A subject undergoes intraocular pressure measurement with tonometer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fluid pressure inside the eye (intraocular pressure) measured in millimeters of mercury (mm Hg)	Intraocular Pressure (IOP) measurements acquired with the study tonometer are compared to the reference tonometer IOP measurements to demonstrate that they meet the requirement specified in the tonometer standards (ISO 8612:2009, JIS T7312:2015 and ANSI Z80.10-2014)	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be 18 years of age or older at the time of informed consent
Irrespective of sex
Irrespective of race or ethnicity
Be willing and able to provide written informed consent by subject or legally designated representative prior to any study procedures

Exclusion Criteria:

Have only one functional eye
Have one eye with poor or eccentric fixation
Have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye
Have microphthalmos in either eye
Have buphthalmos in either eye
Be a contact lens wearer (persons wearing soft contact lenses within the past 3 months and/or hard contact lenses within the past 6 months)
Have dry eyes (persons who have been diagnosed by a physician and are currently using prescription drugs or routinely using artificial tears)
Uncontrollably blink, squint, wink, twitch or squeeze eye(s) - blepharospasm
Have nystagmus in either eye
Have keratoconus in either eye
Have any other corneal or conjunctival pathology or infection in either eye
Have central corneal thickness is less than 500μm or more than 600μm
Be allergic to eye drop anesthetics
Be allergic to sodium fluorescein

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 undergoing routine eye exam at eye care clinic

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Kato Eye Clinic		Tokyo			Japan
Seiyo Clinic

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided