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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02624427
Other study ID # Corvis and DCT vs. GAT
Secondary ID
Status Completed
Phase N/A
First received November 27, 2015
Last updated June 20, 2017
Start date December 2015
Est. completion date November 2016

Study information

Verified date June 2017
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date November 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Outcome

Type Measure Description Time frame Safety issue
Primary Delta IOP IOP difference of Goldmann tonometer and Dynamic Contour tonometer baseline
Secondary 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). baseline
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