- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00406224
Effect of Oxygen Breathing on Flicker Induced Blood Flow Changes in the Optic Nerve Head
Background It has recently been shown that diffuse luminance flicker increases retinal and optic nerve head blood flow. This indicates that a neuro-vascular coupling between neural activity and blood flow exists as described previously for the brain. Although a lot of mediators such as NO, pO2, pCO2, H+ and K+ have been proposed, the mechanism of this coupling is still a matter of controversy. However, it has been shown in an animal experiment, that an increase in blood flow, evoked by diffuse luminance flicker stimulation is paralleled by an decrease in pO2 in the tissue. Thus, in this study we set out to investigate the flicker light induced increase in blood flow under elevated blood pO2.
Study rationale The motive for the investigation of retinal blood flow regulation is to enhance our understanding of the coupling mechanism between increased neural activity and blood flow in the retina in order to gain new insight in the pathophysiology of several eye diseases associated with ocular vascular disorders Study objectives To test the hypothesis whether oxygen breathing influences flicker light induced changes in optic nerve head blood flow
Study Overview
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Retinal vessel diameters
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FliOxyGen
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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