NCT02990169

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

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
15 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

1.7 years

First QC Date

November 28, 2016

Last Update Submit

October 19, 2018

Conditions

Ocular Hypotension

Outcome Measures

Primary Outcomes (2)

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

    From date of randomization until 24 hours

  • 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

Study Arms (2)

Goldmann Tonometer

ACTIVE COMPARATOR

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

Device: Goldmann Tonometer prism

CATS tonometer

ACTIVE COMPARATOR

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

Device: CATS tonometer prism

Interventions

CATS tonometer prismDEVICE

IOP tonometer prism for assessment of intraocular pressure

CATS tonometer
Goldmann Tonometer prismDEVICE

IOP tonometer prism for assessment of intraocular pressure

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 Hypotension

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 13, 2016

Study Start

January 1, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 22, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)