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Clinical Evaluation of CATS Tonometer Prism

Primary Purpose

Ocular Hypotension

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 Hypotension

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

Sites / Locations

  • Arizona Eye Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Goldmann Tonometer

CATS tonometer

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 28, 2016
Last Updated
October 19, 2018
Sponsor
Intuor Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02990169
Brief Title
Clinical Evaluation of CATS Tonometer Prism
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
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). 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Goldmann Tonometer
Arm Type
Active Comparator
Arm Description
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
Arm Title
CATS tonometer
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
CATS tonometer prism
Intervention Description
IOP tonometer prism for assessment of intraocular pressure
Intervention Type
Device
Intervention Name(s)
Goldmann Tonometer prism
Intervention Description
IOP tonometer prism for assessment of intraocular pressure
Primary Outcome Measure Information:
Title
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
Title
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

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 between 0.600 mm and 0.500 mm (more than 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

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Clinical Evaluation of CATS Tonometer Prism

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