NCT02989909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

November 28, 2016

Last Update Submit

August 6, 2018

Conditions

Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Goldmann Tonometer

ACTIVE COMPARATOR

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

Device: Goldmann tonometer prism

CATS tonometer

EXPERIMENTAL

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

Device: CATS tonometer prism

Interventions

CATS tonometer prismDEVICE

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

CATS tonometer
Goldmann tonometer prismDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Eye Consultants

Tucson, Arizona, 85710, United States

Location

Related Publications (1)

  • 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.

    PMID: 30796054DERIVED

MeSH Terms

Conditions

Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2016

First Posted

December 12, 2016

Study Start

January 1, 2017

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)