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Evaluation of Corneal Temperature by Infrared Thermography in Glaucoma Patients

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
infrared thermography
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Ophthalmology, University Hospital Basel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

measurement of corneal temperature by infrared thermography

Arm Description

Outcomes

Primary Outcome Measures

Corneal temperature measurement by infrared thermography
measurement of change in corneal temperature starting with first measurement at Baseline and second measurement after 5 minutes

Secondary Outcome Measures

Full Information

First Posted
January 27, 2016
Last Updated
February 25, 2016
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02674074
Brief Title
Evaluation of Corneal Temperature by Infrared Thermography in Glaucoma Patients
Official Title
Evaluation of Corneal Temperature by Infrared Thermography in Glaucoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
measurement of corneal temperature by infrared thermography
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
infrared thermography
Intervention Description
measurement of corneal temperature by infrared thermography before and after cold provocation
Primary Outcome Measure Information:
Title
Corneal temperature measurement by infrared thermography
Description
measurement of change in corneal temperature starting with first measurement at Baseline and second measurement after 5 minutes
Time Frame
2 measurements with interval of 5 minutes starting at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josef Flammer, Prof. MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Ophthalmology, University Hospital Basel
City
Basel
ZIP/Postal Code
4055
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Corneal Temperature by Infrared Thermography in Glaucoma Patients

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