Clinical Study of the Topcon Tonometer TRK-3

NCT05167773 | Completed

• 1 other identifier: THQ-2021-04
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 2

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.

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

tonometer DEVICE

A subject undergoes intraocular pressure measurement with tonometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing routine eye exam at eye care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Topcon Corporation: lead

Study Sites (2)

Kato Eye Clinic

Tokyo, Japan

Location

Seiyo Clinic

Tokyo, Japan

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 22, 2021
• Study Start: October 11, 2021
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)