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CompletedNCT02990169Updated Oct 22, 2018

Clinical Evaluation of CATS Tonometer Prism

An interventional study of CATS tonometer prism and Goldmann Tonometer prism in Ocular Hypotension, sponsored by Intuor Technologies, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-22.

Sponsored by Intuor Technologies, Inc. · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Ocular Hypotension

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Active comparator
    Goldmann Tonometer

    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

  • Active comparator
    CATS tonometer

    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

  • DeviceCATS tonometer prism

    IOP tonometer prism for assessment of intraocular pressure

  • DeviceGoldmann Tonometer prism

    IOP tonometer prism for assessment of intraocular pressure

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What researchers measure

Primary outcomes

  1. 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

  2. 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

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Study locations

1 site
  • Arizona Eye Consultants
    Tucson, Arizona 85710, United States
07

References and documents

Publications

  • 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. PubMed 30796054 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT02990169
Lead sponsor
Intuor Technologies, Inc.
Responsible party
Sponsor
First posted
Dec 13, 2016
Start date
Jan 2017
Primary completion
Oct 2018
Completion
Oct 2018
Last update
Oct 22, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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