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Completed

NCT Number: NCT05167773

Clinical Study of the Topcon Tonometer TRK-3

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.

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Key information

Conditions

Intraocular Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kato Eye Clinic, Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tonometer

Device

A subject undergoes intraocular pressure measurement with tonometer

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Topcon Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 22, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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