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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02674074
Other study ID # EKNZ 120/11
Secondary ID
Status Completed
Phase N/A
First received January 27, 2016
Last updated February 25, 2016
Start date June 2011
Est. completion date September 2013

Study information

Verified date February 2016
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Cantonal Office of Public Health
Study type Interventional

Clinical Trial Summary

Measurement of corneal temperature gives indirect information about the ocular blood flow. For this reason corneal temperature can be used as a surrogate to quantify ocular blood flow. It can be measured by means of infrared thermography. This test, however, is not used in an everyday clinical routine so far. In this study is investigated if ocular blood flow disturbances in glaucoma patients can be diagnosed by means of infrared thermography.

Corneal temperature are measured in normal tension glaucoma patients and healthy controls before and after cold provocation test. In the group of patients and the group of controls, subjects with and without a primary vascular dysregulation (PVD) are included. This will allow to analyze and compare the influence of cold provocation on corneal temperature (and indirectly ocular blood flow) in these study Groups.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria for Patients:

- Glaucoma

- Age 18-65

Exclusion Criteria for patients:

- No Glaucoma

- Alcohol consumption

- Smoking

Inclusion Criteria for Control:

- No Glaucoma

- Age 18-65

Exclusion Criteria for control:

- Alcohol consumption

- Smoking

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
infrared thermography
measurement of corneal temperature by infrared thermography before and after cold provocation

Locations

Country Name City State
Switzerland Department of Ophthalmology, University Hospital Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Corneal temperature measurement by infrared thermography measurement of change in corneal temperature starting with first measurement at Baseline and second measurement after 5 minutes 2 measurements with interval of 5 minutes starting at baseline No
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