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COMPLETED
NCT07152808

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

Sponsor: Nidek Co. LTD.

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.

Official title: Clinical Pilot Study to Provide Research Data for TONOREF III Tested to ANSI Z80.10-2014

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2022-09-02

Completion Date

2023-06-19

Last Updated

2026-04-24

Healthy Volunteers

Yes

Interventions

DEVICE

NIDEK TONOREF III

The auto ref/kerato/tono/pachymeter TONOREF III is a medical device which measures objective refractive errors, corneal curvature radius, intraocular pressure and corneal thickness of the patient's eye.

DEVICE

Haag-Streit Goldmann Manual Tonometer

Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma