Clinical Trial

Clinical Study for TONOREF III Tested to ANSI Z80.10-2014

Completed
View on ClinicalTrials.gov →
Summary
The primary objective of this clinical study was to show that tonometry values for TONOREF III, as the representative device of the NIDEK tonometer series, were comparable to the predicate device. The secondary objective was to demonstrate that the test device was as safe as the predicate device.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-08-26; most recent amendment 2026-04-06.
Status change: Withheld → Completed 2025-12-04
Trial Details
NCT Number NCT07152808
Lead Sponsor Nidek Co. LTD.
Conditions Intraocular Pressure
Enrollment 52 participants
Start Date 2022-09-02
Primary Completion 2023-06-19 (estimated)
Study Completion 2023-06-19 (estimated)
Updated on ClinicalTrials.gov 2026-04-24