Clinical Evaluation of CATS Tonometer Prism

Intuor Technologies, Inc.86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ocular Hypertension

Interventions

CATS tonometer prismDEVICE

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

Goldmann tonometer prismDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Arizona Eye Consultants

Tucson, Arizona, United States

Outcomes

Primary Outcomes

All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings in establishing effectiveness.

Time frame: From date of randomization until 24 hours

Data from ClinicalTrials.gov

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