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Clinical Study for TONOREF III Tested to ANSI Z80.10-2014
Sponsor: Nidek Co. LTD.
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
Conditions
Interventions
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.
Haag-Streit Goldmann Manual Tonometer
Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma