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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
225
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.
Andover Eye Associates
Andover, Massachusetts, United States
Agreement of Intraocular Pressure
Agreement of the measured IOP between the test device and the predicate device for the tonometer function of NIDEK TONOREF III. The mean difference and the standard deviation between these two devices are shown in the outcome measures table.
Time frame: 1 day
Agreement of Corneal Thickness
Agreement of the measured corneal thickness between the test device and the predicate device for the pachymeter function of the NIDEK TONOREF III. The mean difference and the standard deviation between these two devices are shown in the outcome measure table.
Time frame: 1 day
Number of Occurrences of Adverse Events
Any sight threatening adverse event associated with the test and predicate devices.
Time frame: 1day
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