Clinical Study of the Topcon Tonometer TRK-3
NCT05167773 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 139
Last updated 2022-07-20
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.
Conditions
- Intraocular Pressure
Interventions
- DEVICE
-
tonometer
A subject undergoes intraocular pressure measurement with tonometer
Sponsors & Collaborators
-
Topcon Corporation
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-11
- Primary Completion
- 2022-01-14
- Completion
- 2022-01-14
Countries
- Japan
Study Locations
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