Clinical Study of the Topcon Tonometer TRK-3

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

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.

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure
• Intervention / Treatment: Device: tonometer

• Study Type: Observational
• Enrollment (Actual): 139

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Kato Eye Clinic
  • Tokyo, Japan
    • Seiyo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing routine eye exam at eye care clinic

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Have only one functional eye
2. Have one eye with poor or eccentric fixation
3. Have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye
4. Have microphthalmos in either eye
5. Have buphthalmos in either eye
6. 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)
7. Have dry eyes (persons who have been diagnosed by a physician and are currently using prescription drugs or routinely using artificial tears)
8. Uncontrollably blink, squint, wink, twitch or squeeze eye(s) - blepharospasm
9. Have nystagmus in either eye
10. Have keratoconus in either eye
11. Have any other corneal or conjunctival pathology or infection in either eye
12. Have central corneal thickness is less than 500μm or more than 600μm
13. Be allergic to eye drop anesthetics
14. Be allergic to sodium fluorescein

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Topcon Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 11, 2021
• Primary Completion (ACTUAL): January 14, 2022
• Study Completion (ACTUAL): January 14, 2022

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (ACTUAL): December 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: THQ-2021-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No