Clinical Evaluation of CATS Tonometer Prism

Not Applicable

Completed

• Conditions: Ocular Hypertension
• Interventions: Device: Goldmann tonometer prism; Device: CATS tonometer prism

• Registration Number: NCT02989909
• Lead Sponsor: Intuor Technologies, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-12
• Study Start: 2017-01
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goldmann Tonometer	Goldmann tonometer prism	Goldmann Tonometer prism will be used as a based line comparator for tolerance assessment versus the active test comparator CATS tonometer prism
CATS tonometer	CATS tonometer prism	CATS tonometer prism being used as the test product to assess IOP measurement versus active comparator the Goldmann Tonometer prism

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Arizona Eye Consultants; 🇺🇸 Tucson, Arizona, United States