NCT02674074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

2.3 years

First QC Date

January 27, 2016

Last Update Submit

February 25, 2016

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

measurement of corneal temperature by infrared thermography

EXPERIMENTAL
Device: infrared thermography

Interventions

infrared thermographyDEVICE

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

measurement of corneal temperature by infrared thermography

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Glaucoma
  • Age 18-65

You may not qualify if:

  • No Glaucoma
  • Alcohol consumption
  • Smoking
  • No Glaucoma
  • Age 18-65
  • Alcohol consumption
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, University Hospital Basel

Basel, Basel, 4055, Switzerland

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Josef Flammer, Prof. MD

    University Hospital, Basel, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 4, 2016

Study Start

June 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

February 26, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)