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Clinical Evaluation of CATS Tonometer Prism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990169
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Intuor Technologies, Inc.

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.

Condition or disease Intervention/treatment Phase
Ocular Hypotension Device: CATS tonometer prism Device: Goldmann Tonometer prism Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : January 2017
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Arm Intervention/treatment
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
IOP tonometer prism for assessment of intraocular pressure

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
IOP tonometer prism for assessment of intraocular pressure




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990169


Locations
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United States, Arizona
Arizona Eye Consultants
Tucson, Arizona, United States, 85710
Sponsors and Collaborators
Intuor Technologies, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Intuor Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02990169    
Other Study ID Numbers: CATS and Corneal Thickness
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Ocular Hypotension
Hypotension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases