Clinical Study of the Topcon Tonometer TRK-3

Completed

• Conditions: Intraocular Pressure

• Registration Number: NCT05167773
• Lead Sponsor: Topcon Corporation

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 available

Study Timeline

• Study Start: 2021-10-11
• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2021-12-22
• Primary Completion: 2022-01-14
• Study Completion: 2022-01-14
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

Kato Eye Clinic; 🇯🇵 Tokyo, Japan

Seiyo Clinic; 🇯🇵 Tokyo, Japan