An interventional study of NIDEK TONOREF III and Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER in Intraocular Pressure, sponsored by Nidek Co. LTD.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by Nidek Co. LTD. · Not applicable, Interventional, and Diagnostic
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.
Nidek Co. LTD. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
NIDEK TONOREFIII
Device: NIDEK TONOREF III · Device: Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER · Device: NIDEK CEM-530
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
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.
Equivalent to legally-marketed devices
Agreement of intraocular pressure (mmHg) measurement for TONOREFIII and PAT
Time frame: One or two study visits per subject. One visit is less than two hours.
Equivalent to the pachymeter function
Agreement of central corneal thickness (µm) measurement for TONOREF III and CEM-530
Time frame: One or two study visits per subject. One visit is less than two hours.
The numbers of adverse events
To demonstrate that the test device is as safe as the predicate devices.
Time frame: One or two study visits per subject. One visit is less than two hours.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Nidek Co. LTD.