The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek Non Contact Tono/ Pachymeter NT-530P. The secondary objective is to evaluate any adverse events found during the clinical study.
Following data analysis will be conducted for tonometer and pachymeter readings. One of eyes of one patient becomes an object of the analysis. Regarding the intraocular pressure, higher IOP readings of either right or left eye are used for analysis. Regarding CCT, the readings of either right or left eye are randomly assigned to analysis in the order of registration.
Study Type
INTERVENTIONAL
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
250
intraocular pressure and central corneal thickness measurement
Kaiya ophthalmological clinic
Hamamatsu, Shizuoka, Japan
Ochanomizu Inoue ophthalmological clinic
Tokyo, Japan
central corneal thickness
Time frame: one day
intraocular pressure
Time frame: one day
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