- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00812526
Regulation of Choroidal Blood Flow During Combined Changes in Intraocular Pressure and Arterial Blood Pressure
December 19, 2008 updated by: Medical University of Vienna
Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in perfusion pressure.
For a long time it had been assumed that the choroid is a strictly passive vascular bed, which shows no autoregulation.
However, recently several groups have identified some autoregulatory capacity of the choroid.
Choroidal autoregulation was first shown in a rabbit model where intraocular pressure (IOP) and arterial blood pressure could be varied independently.
In these experiments regulation of choroidal blood flow was not only dependent on ocular perfusion pressure, but was also dependent on the value of IOP.
This indicates that a myogenic mechanism contributes to choroidal autoregulation, because the regulatory capacity is dependent on the transmural pressure.
In the model of myogenic autoregulation arterioles change their vascular tone depending on the pressure inside the vessel and outside the vessel.
The present experiments are designed to test whether a myogenic mechanism may also be involved in choroidal autoregulation in humans.
For this purpose the investigators perform experiments during which the IOP and the arterial blood pressure is increased.
According to the myogenic theory of autoregulation one would expect stronger vasoconstriction at lower IOPs for the same increase in ocular perfusion pressure.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
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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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
19 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Men aged between 19 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 ophthalmic findings, ametropia < 1 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
- Presence of intraocular pathology: ocular hypertension, glaucoma, retinal vasculopathy or other retinal diseases
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Relationship between ocular perfusion pressure and choroidal blood flow
Time Frame: 4 study days
|
4 study days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Choroidal blood flow
Time Frame: 4 study days
|
4 study days
|
|
Mean arterial pressure
Time Frame: 4 study days
|
4 study days
|
|
Intraocular pressure
Time Frame: 4 study days
|
4 study days
|
|
Systolic/diastolic blood pressure
Time Frame: 4 study days
|
4 study days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Elzbieta Polska, MD, Department of Clinical Pharmacology, Medical University of Vienna
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
September 1, 2002
Primary Completion (Actual)
September 1, 2004
Study Completion (Actual)
September 1, 2004
Study Registration Dates
First Submitted
December 18, 2008
First Submitted That Met QC Criteria
December 19, 2008
First Posted (Estimate)
December 22, 2008
Study Record Updates
Last Update Posted (Estimate)
December 22, 2008
Last Update Submitted That Met QC Criteria
December 19, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- OPHT-190702
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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