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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05167773
Other study ID # THQ-2021-04
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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