Ocular Hemodynamic Effects of Nitrovasodilators in Healthy Subjects
NCT ID: NCT00810381
Last Updated: 2008-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
1999-01-31
1999-06-30
Brief Summary
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The IOP lowering potential and the vasodilator action in retinal and choroidal vessels of nitrates is still a matter of controversy. Previous studies on the ocular hemodynamic effects of nitrates showed partially contradicting results. In addition the IOP lowering effect of nitrates is still unclear. However, recent studies show that long acting nitrates may preserve optic nerve deterioration and visual field loss.
Therefore, the role of nitrovasodilators in control of ocular blood flow and intraocular pressure has to be elucidated. For this purpose the investigators plan to test the hypothesis that nitrovasodilators improve ocular blood supply to the optic nerve head at doses which do not affect systemic hemodynamics.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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1
Nitroglycerin: (Perlinganit, Nycomet Heilmittelwerke, Vienna, Austria):
0, 0.25, 0.5, 1, 1.5 and 2 µg/kg/min, each infusion step for 20 minutes
Nitroglycerin
intravenous infusion; 0, 0.125, 0.25, 0.5, 1 and 2 µg/kg/min; 20 minutes per infusion step
2
Isosorbide-Dinitrate: (Isoket 0,1 %, Gebro Broschek, Fieberbrunn, Austria):
0, 0.5, 1, 2, 4 and 6 µg/kg/min , each infusion step for 20 minutes
Isosorbide-Dinitrate
intravenous infusion; 0, 0.5, 1, 2, 4, and 6 µg/kg/min; 20 minutes per infusion step
3
Sodium-Nitroprusside: (Nipruss, Sanol-Schwarz, Monheim, Germany):
0, 0.25, 0.5, 1, 2 and 4 µg/kg/min, each infusion step for 20 minutes
Sodium-nitroprusside
intravenous infusion; 0, 0.25, 0.5, 1, 2, and 4 µg/kg/min; 20 minutes per infusion step
4
Physiologic saline solution
Physiologic saline solution (control substance)
intravenous infusion, infusion period 120 minutes
Interventions
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Nitroglycerin
intravenous infusion; 0, 0.125, 0.25, 0.5, 1 and 2 µg/kg/min; 20 minutes per infusion step
Isosorbide-Dinitrate
intravenous infusion; 0, 0.5, 1, 2, 4, and 6 µg/kg/min; 20 minutes per infusion step
Sodium-nitroprusside
intravenous infusion; 0, 0.25, 0.5, 1, 2, and 4 µg/kg/min; 20 minutes per infusion step
Physiologic saline solution (control substance)
intravenous infusion, infusion period 120 minutes
Eligibility Criteria
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Inclusion Criteria
* Body mass index between 15th and 85th percentile (Must et al. 1991)
* 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, ametropia \< 3 Dpt.
Exclusion Criteria
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* History of migraine
* Blood donation during the previous 3 weeks
19 Years
35 Years
MALE
Yes
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Department of Clinical Pharmacology, Medical University of Vienna
Principal Investigators
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Hans-Georg Eichler, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Pharmacology, Medical University of Vienna
Locations
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Department of Clinical Pharmacology, Medical University of Vienna
Vienna, , Austria
Countries
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Other Identifiers
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OPHT-211097
Identifier Type: -
Identifier Source: org_study_id