Trials / Completed
CompletedNCT05167773
Clinical Study of the Topcon Tonometer TRK-3
Clinical Study of the Topcon Tonometer TRK-3 to Demonstrate Conformance to ISO 8612, JIS T7312, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 139 (actual)
- Sponsor
- Topcon Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | tonometer | A subject undergoes intraocular pressure measurement with tonometer |
Timeline
- Start date
- 2021-10-11
- Primary completion
- 2022-01-14
- Completion
- 2022-01-14
- First posted
- 2021-12-22
- Last updated
- 2022-07-20
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT05167773. Inclusion in this directory is not an endorsement.