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Clinical Evaluation of CATS Tonometer Prism

Primary Purpose

Ocular Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CATS tonometer prism
Goldmann tonometer prism
Sponsored by
Intuor Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Arizona Eye Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Goldmann Tonometer

CATS tonometer

Arm Description

Goldmann Tonometer prism will be used as a based line comparator for tolerance assessment versus the active test comparator CATS tonometer prism

CATS tonometer prism being used as the test product to assess IOP measurement versus active comparator the Goldmann Tonometer prism

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 28, 2016
Last Updated
August 6, 2018
Sponsor
Intuor Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02989909
Brief Title
Clinical Evaluation of CATS Tonometer Prism
Official Title
Clinical Evaluation of CATS Tonometer Prism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intuor Technologies, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goldmann Tonometer
Arm Type
Active Comparator
Arm Description
Goldmann Tonometer prism will be used as a based line comparator for tolerance assessment versus the active test comparator CATS tonometer prism
Arm Title
CATS tonometer
Arm Type
Experimental
Arm Description
CATS tonometer prism being used as the test product to assess IOP measurement versus active comparator the Goldmann Tonometer prism
Intervention Type
Device
Intervention Name(s)
CATS tonometer prism
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Goldmann tonometer prism
Intervention Description
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Arizona Eye Consultants
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30796054
Citation
McCafferty SJ, Tetrault K, McColgin A, Chue W, Levine J, Muller M. Modified Goldmann prism intraocular pressure measurement accuracy and correlation to corneal biomechanical metrics: multicentre randomised clinical trial. Br J Ophthalmol. 2019 Dec;103(12):1840-1844. doi: 10.1136/bjophthalmol-2018-313470. Epub 2019 Feb 22.
Results Reference
derived

Learn more about this trial

Clinical Evaluation of CATS Tonometer Prism

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