Regulation of Choroidal Blood Flow During Combined Changes in Intraocular Pressure and Arterial Blood Pressure
1 other identifier
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2002
Typical duration for not_applicable
1 active site
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
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 18, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedDecember 22, 2008
December 1, 2008
2 years
December 18, 2008
December 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relationship between ocular perfusion pressure and choroidal blood flow
4 study days
Secondary Outcomes (4)
Choroidal blood flow
4 study days
Mean arterial pressure
4 study days
Intraocular pressure
4 study days
Systolic/diastolic blood pressure
4 study days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090, Austria
Study Officials
- STUDY DIRECTOR
Elzbieta Polska, MD
Department of Clinical Pharmacology, Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 18, 2008
First Posted
December 22, 2008
Study Start
September 1, 2002
Primary Completion
September 1, 2004
Study Completion
September 1, 2004
Last Updated
December 22, 2008
Record last verified: 2008-12