Clinical Evaluation of CATS Tonometer Prism

Not Applicable

Completed

• Conditions: Ocular Hypotension
• Interventions: Device: CATS tonometer prism; Device: Goldmann Tonometer prism

• Registration Number: NCT02990169
• 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). 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-13
• Study Start: 2017-01
• Status Verified: 2018-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CATS tonometer	CATS tonometer prism	determine if the CATS tonometer prism effectively reduces sensitivity to IOP errors produced by corneal thickness and therefore provides a more accurate IOP reading compared to the reference tonometer (Goldmann prism), based upon the correction value table for Goldmann tonometer prism
Goldmann Tonometer	Goldmann Tonometer prism	determine if the CATS tonometer prism effectively reduces sensitivity to IOP errors produced by corneal thickness and therefore provides a more accurate IOP reading compared to the reference tonometer (Goldmann prism), based upon the correction value table for Goldmann tonometer prism

Primary Outcome Measures

Name	Time	Method
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.	From date of randomization until 24 hours
All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings.	From date of randomization until 24 hours

Trial Locations

Locations (1)

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