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). Seventy-five (75) Subjects 18 and older and will be enrolled. Subjects will be screened based on standard of care vision examination at the clinical investigation sites. All subjects will undergo a standard ophthalmic exam and informed consent. IOP will be measured using a Goldmann tonometer armature with both the standard flat GAT prism and the modified curved CATS prism alternately inserted. The only additional measurement is central corneal thickness (CCT) which is used to correct for one of the corneal biomechanical errors seen in the GAT prism and is currently standard of care.

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Key information

Conditions

Ocular Hypotension 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 between 0.600 mm and 0.500 mm (more than 2 standard deviations about the human mean)

Treatment and study plan

CATS tonometer prism

Device

IOP tonometer prism for assessment of intraocular pressure

Goldmann Tonometer prism

Device

IOP tonometer prism for assessment of intraocular pressure

Primary outcomes

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

Time frame: From date of randomization until 24 hours
All subjects will have corneal thickness measurements performed and the CATS tonometer prism intraocular pressure readings will be compared to Goldmann tonometer readings using a correction value table.

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: 2018
Study completion: 2018
First posted: Dec 13, 2016
Registry last updated: Oct 22, 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.

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