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

Study Overview
=================
Brief 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.

Official Title
-----------------
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)

Conditions
-----------------
Intraocular Pressure

Intervention / Treatment
-----------------
* Device: Nidek Tonoref III
* Device: Haag-Streit Goldmann Manual Tonometer
* Device: NIDEK CEM-530


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be at least 18 years of age of either sex and any race or ethnicity; be willing and able to provide written informed consent prior to any study procedures being performed; be willing and able to follow all instructions and attend all study visits; Exclusion Criteria: have only one functional eye; have poor or eccentric fixation in either eye; have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye; have microphthalmos in either eye; have buphthalmos in either eye; be a contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months; have dry eyes, meaning having been diagnosed by a physician with dry eyes and currently using a prescribed medication or daily use of artificial tears; be a lid squeezer - blepharospasm; have nystagmus in either eye; have keratoconus in either eye; have any other corneal or conjunctival pathology or infection in either eye; have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adults 18 years old or older<br>Nidek Tonoref III | Device: Nidek Tonoref III<br>* 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.<br>Device: Haag-Streit Goldmann Manual Tonometer<br>* Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma<br>Device: NIDEK CEM-530<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Occurrences of Adverse Events | Any sight threatening adverse event associated with the test and predicate devices. | 1day |