Clinical Study of the Topcon Tonometer TRK-3

Intraocular Pressure Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05167773
• Other study ID #: THQ-2021-04
• Status: Completed
• Start date: October 11, 2021
• Est. completion date: January 14, 2022

Study information

• Verified date: July 2022
• Source: Topcon Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Device:
• tonometer
A subject undergoes intraocular pressure measurement with tonometer

Locations

Country	Name	City	State
Japan	Kato Eye Clinic	Tokyo
Japan	Seiyo Clinic	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Topcon Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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