At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Pilot Study to Provide Research Data for TONOREF III Tested to ANSI Z80.10-2014
In Brief
A clinical study evaluating NIDEK TONOREF III and Haag-Streit Goldmann Manual Tonometer for Intraocular Pressure. Completed, enrolled 52 participants.
Detailed 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.
Study Details
Timeline
Interventions
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 measures intraocular pressure to aid in the screening and diagnosis of glaucoma