Clinical Study of the Topcon Tonometer TRK-3

• Sponsor: Topcon Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05167773
• Collaborator: (none)
• Enrollment: 139
• Locations: 2
• Actual Duration (Months): 3.1
• Patients Per Site: 69.5
• Patients Per Site Per Month: 22.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Pressure	Device: tonometer

Study Design

• Study Type: Observational
• Actual Enrollment: 139 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Oct 11, 2021
• Actual Primary Completion Date: Jan 14, 2022
• Actual Study Completion Date: Jan 14, 2022

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kato Eye Clinic	Tokyo		Japan
2	Seiyo Clinic	Tokyo		Japan

Sponsors and Collaborators

• Topcon Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Topcon Corporation
• ClinicalTrials.gov Identifier: NCT05167773
• Other Study ID Numbers: THQ-2021-04
• First Posted: Dec 22, 2021
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Jul 20, 2022