Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer and Topcon SP-1P

Study Overview
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Brief Summary
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The study will assess the CT-800 and TRK-2P for conformity 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. This clinical device study will also assess the substantial equivalence of TRK-2P to a predicate device in regard to pachymetry.

Official Title
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Comparative Study of the Topcon Tonometers CT-800 and TRK-2P 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 Topcon TRK-2P With the Topcon SP-1P (Predicate)

Conditions
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Intraocular Pressure

Intervention / Treatment
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* Device: Topcon CT-800
* Device: Topcon TRK-2P


Participation Criteria
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Eligibility Criteria
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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 an artificial tear; 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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults 18 years old or older<br> | Device: Topcon CT-800<br>* tonometer<br>Device: Topcon TRK-2P<br>* tonometer, pachymeter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement of IOP | Agreement of the measured IOP between the test devices and the predicate device for the tonometer function of CT-800 and TRK-2P. Presentation of results and analyses will include descriptive statistics (mean, standard deviation, limits of agreement), Bland-Altman plot and linear regression. | 1 day | 
| Agreement of Corneal Thickness | Agreement of measured corneal thickness between the test device and the predicate device for the pachymeter function of the TRK-2P. Presentation of results and analyses will include descriptive statistics (mean, standard deviation, limits of agreement), Bland-Altman plot and Deming regression. | 1 day |