Clinical Study of the Topcon Tonometer TRK-3

Topcon

Status: Completed

Conditions: Intraocular Pressure

Treatments: Device: tonometer

Study type: Observational

Funder types: Industry

Identifiers

NCT05167773

THQ-2021-04

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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