NCT03441477

Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530

Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer (Predicate) to Demonstrate Conformance to ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530 (Predicate)

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Nidek Co. LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices.

Conditions

• Intraocular Pressure

Interventions

Type	Name	Description
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
DEVICE	NIDEK CEM-530	Nidek CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera used for examination of the corneal endothelium and for measurement of the thickness of the cornea.

Timeline

• Start date: 2017-12-17
• Primary completion: 2019-01-16
• Completion: 2019-01-16
• First posted: 2018-02-22
• Last updated: 2023-07-03
• Results posted: 2022-02-11

Locations

1 site across 1 country: United States