Clinical Evaluation of CATS Tonometer Prism

Study Overview
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Brief Summary
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Prospective, open-labeled, randomized, controlled, multicenter study at two clinical investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT). Of the 200 eyes, at least 10 highly astigmatic eyes (>3 D of corneal astigmatism) each in the low, medium and high IOP ranges shall have the same clinical testing and analysis of results, with the analysis kept separate from that of the main group.

Official Title
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Clinical Evaluation of CATS Tonometer Prism

Conditions
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Ocular Hypertension

Intervention / Treatment
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* Device: CATS tonometer prism
* Device: Goldmann tonometer prism


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent (and assent when applicable)obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. Male and female patients, at least 18 years of age Exclusion Criteria: Subject has undergone ocular surgery within the last 3 months Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk Pregnant or nursing women Subjects with only one functional eye Those with one eye having poor or eccentric fixation Eyes displaying an oval contact image Those with corneal scarring or who have had corneal surgery including corneal laser surgery Microphthalmos Buphthalmos Contact lens wearers Severe Dry eyes Lid squeezers - blepharospasm Nystagmus Keratoconus Any other corneal or conjunctival pathology or infection. Central corneal thickness greater than 0.600 mm or less than 0.500 mm (2 standard deviations about the human mean)

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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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Goldmann Tonometer<br>Goldmann Tonometer prism will be used as a based line comparator for tolerance assessment versus the active test comparator CATS tonometer prism | Device: Goldmann tonometer prism<br>* demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range<br>|
| Experimental: CATS tonometer<br>CATS tonometer prism being used as the test product to assess IOP measurement versus active comparator the Goldmann Tonometer prism | Device: CATS tonometer prism<br>* demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings in establishing effectiveness. |  | From date of randomization until 24 hours |