Evaluation of Corneal Temperature by Infrared Thermography in Glaucoma Patients

February 25, 2016 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4055
        • Department of Ophthalmology, University Hospital Basel

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: measurement of corneal temperature by infrared thermography
Device: infrared thermography
measurement of corneal temperature by infrared thermography before and after cold provocation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal temperature measurement by infrared thermography
Time Frame: 2 measurements with interval of 5 minutes starting at baseline
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

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Study Chair: Josef Flammer, Prof. MD, University Hospital, Basel, Switzerland

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

June 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNZ 120/11

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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