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Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and Corvis ST Tonometer

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Measurement of intraocular pressure (IOP)
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring Glaucoma, Intraocular Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for the glaucoma group:

  • diagnosis of glaucoma
  • 18 years old or older with no upper limit

Exclusion Criteria for the glaucoma group:

  • IOP lowering surgery within the last 3 weeks
  • any corneal surgery in the past
  • bad fixation
  • insufficient measurement quality with any of the study devices

Inclusion Criteria for the healthy control group:

  • no diagnosis of glaucoma
  • 18 years old or older with no upper limit

Exclusion Criteria for the healthy control group:

  • any diagnosis of glaucoma
  • IOP lowering surgery within the last 3 weeks
  • any corneal surgery in the past
  • bad fixation
  • insufficient measurement quality with any of the study devices

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Glaucoma Eyes

    Healthy Eyes

    Arm Description

    Measurement of intraocular pressure (IOP)

    age-matched healthy eyes as controls will undergo Measurement of intraocular pressure (IOP)

    Outcomes

    Primary Outcome Measures

    Delta IOP
    IOP difference of Goldmann tonometer and Dynamic Contour tonometer

    Secondary Outcome Measures

    Correlation of IOP difference of Goldmann tonometer and Dynamic Contour tonometer with biomechanical corneal properties measured by Corvis ST tonometer
    Corvis ST has an integrated high-speed Scheimpflug camera which records images on which basis the biomechanical corneal parameter are analyzed (corneal thickness in micrometers, corneal applications in millimeters, peak distance in millimeters, radius in millimeters, and deformation amplitude in millimeters). Those biomechanical parameters of the cornea will be correlated to the difference of the IOP measured by GAT and by DCT (GAT - DCT).

    Full Information

    First Posted
    November 27, 2015
    Last Updated
    June 20, 2017
    Sponsor
    University of Zurich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02624427
    Brief Title
    Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and Corvis ST Tonometer
    Official Title
    Comparison of Intraocular Pressure Measured by Goldmann Applanation Tonometry and Dynamic Contour Tonometry vs. Corvis ST Tonometer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Zurich

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study is investigating Intra ocular pressure (IOP) by Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and the Corvis ST tonometer.
    Detailed Description
    The aim of the study is to approach the "true" Intra ocular pressure (IOP) by correlating the difference between IOP by Goldmann Applanation Tonometry to the IOP by Dynamic Contour Tonometry to the biomechanical parameters of the cornea measured by Corvis ST. Therefore the investigators gain new findings about the influence of the biomechanical corneal parameters on the IOP. In order to do so the investigators want to examine 50 Glaucoma eyes and 50 non-Glaucoma Eyes with Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and Corvis ST.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma
    Keywords
    Glaucoma, Intraocular Pressure

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Glaucoma Eyes
    Arm Type
    Experimental
    Arm Description
    Measurement of intraocular pressure (IOP)
    Arm Title
    Healthy Eyes
    Arm Type
    Active Comparator
    Arm Description
    age-matched healthy eyes as controls will undergo Measurement of intraocular pressure (IOP)
    Intervention Type
    Device
    Intervention Name(s)
    Measurement of intraocular pressure (IOP)
    Intervention Description
    Measurement of IOP with the following devices: (1) Goldmann tonometer, (2) Dynamic Contour tonometer, and (3) Corvis ST tonometer
    Primary Outcome Measure Information:
    Title
    Delta IOP
    Description
    IOP difference of Goldmann tonometer and Dynamic Contour tonometer
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Correlation of IOP difference of Goldmann tonometer and Dynamic Contour tonometer with biomechanical corneal properties measured by Corvis ST tonometer
    Description
    Corvis ST has an integrated high-speed Scheimpflug camera which records images on which basis the biomechanical corneal parameter are analyzed (corneal thickness in micrometers, corneal applications in millimeters, peak distance in millimeters, radius in millimeters, and deformation amplitude in millimeters). Those biomechanical parameters of the cornea will be correlated to the difference of the IOP measured by GAT and by DCT (GAT - DCT).
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria for the glaucoma group: diagnosis of glaucoma 18 years old or older with no upper limit Exclusion Criteria for the glaucoma group: IOP lowering surgery within the last 3 weeks any corneal surgery in the past bad fixation insufficient measurement quality with any of the study devices Inclusion Criteria for the healthy control group: no diagnosis of glaucoma 18 years old or older with no upper limit Exclusion Criteria for the healthy control group: any diagnosis of glaucoma IOP lowering surgery within the last 3 weeks any corneal surgery in the past bad fixation insufficient measurement quality with any of the study devices
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jens Funk, MD PhD
    Organizational Affiliation
    UniversityHospital of Zurich, Zurich, Switzerland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    http://www.usz.ch
    Description
    Study Center

    Learn more about this trial

    Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and Corvis ST Tonometer

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