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

June 20, 2017 updated by: University of Zurich

Comparison of Intraocular Pressure Measured by Goldmann Applanation Tonometry and Dynamic Contour Tonometry vs. Corvis ST Tonometer

The study is investigating Intra ocular pressure (IOP) by Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and the Corvis ST tonometer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glaucoma Eyes
Measurement of intraocular pressure (IOP)
Device: Measurement of intraocular pressure (IOP)
Measurement of IOP with the following devices: (1) Goldmann tonometer, (2) Dynamic Contour tonometer, and (3) Corvis ST tonometer
Active Comparator: Healthy Eyes
age-matched healthy eyes as controls will undergo Measurement of intraocular pressure (IOP)
Device: Measurement of intraocular pressure (IOP)
Measurement of IOP with the following devices: (1) Goldmann tonometer, (2) Dynamic Contour tonometer, and (3) Corvis ST tonometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delta IOP
Time Frame: baseline
IOP difference of Goldmann tonometer and Dynamic Contour tonometer
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of IOP difference of Goldmann tonometer and Dynamic Contour tonometer with biomechanical corneal properties measured by Corvis ST tonometer
Time Frame: baseline
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).
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Jens Funk, MD PhD, UniversityHospital of Zurich, Zurich, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

November 27, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 8, 2015

Study Record Updates

Last Update Posted (Actual)

June 21, 2017

Last Update Submitted That Met QC Criteria

June 20, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Corvis and DCT vs. GAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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