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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 8, 2008 | ||||
| Last Updated Date | July 8, 2008 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
choroidal pressure-flow relationship [ Time Frame: 2 hours at 2 study days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Role of Adenosine in the Control of Choroidal Blood Flow During Changes in Ocular Perfusion Pressure. | ||||
| Official Title ICMJE | Role of Adenosine in the Control of Choroidal Blood Flow During Changes in Ocular Perfusion Pressure. | ||||
| 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 human choroid. In the brain and the retina the mechanism behind autoregulation is most likely linked to changes in transmural pressure. In this model arterioles change their vascular tone depending on the pressure inside the vessel and outside the vessel. In the choroid, several observations argue against a direct involvement of arterioles. However, the mechanism behind choroidal autoregulation remains unclear. Adenosine, an endogenous purine metabolic end product with a potent vasodilatory effect on multiple vascular beds, leads to an increase in retinal and choroidal vessel diameter. The present study aims to investigate whether adenosine plays a role in choroidal autoregulation during a decrease in ocular perfusion pressure, which will be achieved by an increase in intraocular pressure. Pressure/flow relationships will be investigated in the absence and presence of adenosine. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | April 2005 | ||||
| Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00712764 | ||||
| Responsible Party | Michael Wolzt, MD, Department of Clinical Pharmacology, Medical University of Vienna | ||||
| Study ID Numbers ICMJE | OPHT-011206 | ||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Vienna | ||||
| Verification Date | December 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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