Clinical Evaluation of CATS Tonometer Prism

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.

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Key information

Conditions

Ocular Hypertension Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Eye Consultants

Tucson, Arizona, 85710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CATS tonometer prism

Device

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 prism

Device

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

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

Sponsors and collaborators

Lead sponsor

Intuor Technologies, Inc.

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Dec 12, 2016
Registry last updated: Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed