Clinical Evaluation of CATS Tonometer Prism

Ocular Hypertension Clinical Trial

Official title:

Clinical Evaluation of CATS Tonometer Prism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02989909
• Other study ID #: CATS Tonometer, LLC - CP-01
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: November 2017

Study information

• Verified date: August 2018
• Source: Intuor Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ocular Hypertension

Intervention

Device:
• CATS tonometer prism
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
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

Locations

Country	Name	City	State
United States	Arizona Eye Consultants	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Intuor Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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