CompletedNot Applicable

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

52 participantsStarted 2022-09-02

Plain-language 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.

Who can participate

Age range22 Years

SexALL

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Inclusion criteria

✓. been at least 22 years of age of either sex and any race or ethnicity;
✓. been willing and able to provide written informed consent prior to any study procedures being performed;
✓. been willing and able to follow all instructions and attend all study visits;
✓. corneal astigmatism of ≤3D and corneal thickness of 500-600 μm in at least one eye.

Exclusion criteria

✕. have only one functional eye;
✕. have poor or eccentric fixation in the study eye;
✕. have corneal scarring or have had corneal surgery, including corneal laser surgery in the study eye
✕. have microphthalmos in the study eye;
✕. have buphthalmos in the study eye;
✕. be a contact lens wearer in the study eye;
✕. have dry eyes;
✕. be a lid squeezer - blepharospasm;

What they're measuring

Agreement of Intraocular Pressure

Timeframe: 1-2 study visits per subject over the course of 8 days

Trial details

NCT IDNCT07152808

SponsorNidek Co. LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-19

Results submitted2025-12-04

View on ClinicalTrials.gov More Intraocular Pressure trials