Clinical Study of the Topcon Tonometer TRK-3 to Demonstrate Conformance to ISO 8612, JIS T7312, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers

Topcon Corporation2 sites in 1 country139 target enrollmentOctober 11, 2021

ConditionsIntraocular Pressure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intraocular Pressure
Sponsor: Topcon Corporation
Enrollment: 139
Locations: 2
Primary Endpoint: fluid pressure inside the eye (intraocular pressure) measured in millimeters of mercury (mm Hg)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 11, 2021

End Date

January 14, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Topcon Corporation

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

fluid pressure inside the eye (intraocular pressure) measured in millimeters of mercury (mm Hg)

Time Frame: 1 day

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)