- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00719342
Effect of Breathing a Mixture of 92% Oxygen (O2) + 8% Carbon Dioxide (CO2) on Flicker Induced Blood Flow Changes in Ocular Perfusion
November 13, 2014 updated by: Gerhard Garhofer, Medical University of Vienna
Effect of Breathing a Mixture of 92% O2 + 8% CO2 on Flicker Induced Blood Flow Changes in Ocular Perfusion
It has 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 in the retina 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 decrease in pO2 in the tissue.
In a recently performed study we could show that breathing of 100% O2 did not influence flicker induced changes in the retina and optic nerve head.
However, breathing of 100% oxygen also leads to a pronounced vasoconstriction of the retinal vessels and in turn to a increased tension of the vessel wall.
Recent evidence indicates that a combination of 92% O2 and 8% CO2 can, at least partially, counteract the vasoconstrictory effect of O2 and increases tissue pO2.
Thus, in this study the investigators set out to investigate the flicker light induced increase in blood flow under a mixture of O2/CO2 .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
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
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-
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Vienna, Austria, 1090
- Department of Clinical Pharmacology, Medical University of Vienna
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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 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and Women aged between 18 and 35 years, nonsmokers
- Body mass index between 15th and 85th percentile
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 3 Dpt.
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
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: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Optic nerve head blood flow
Time Frame: 1 hour
|
1 hour
|
|
Retinal vessel diameters
Time Frame: 1 hour
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
blood pressure
Time Frame: 1 hour
|
1 hour
|
|
pulse rate
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2008
Primary Completion (ACTUAL)
May 1, 2009
Study Completion (ACTUAL)
December 1, 2009
Study Registration Dates
First Submitted
July 1, 2008
First Submitted That Met QC Criteria
July 17, 2008
First Posted (ESTIMATE)
July 21, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
November 14, 2014
Last Update Submitted That Met QC Criteria
November 13, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OPHT-030606
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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