Intraocular Pressure
Conditions
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.
Interventions
DEVICEtonometer
A subject undergoes intraocular pressure measurement with tonometer
Sponsors
Topcon Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Japan
Outcome results
None listed