Role of Nitrogen Oxide (NO) in the Control of Choroidal Blood Flow During a Decrease in Ocular Perfusion Pressure
NCT ID: NCT00810927
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
PHASE2
22 participants
INTERVENTIONAL
2003-09-30
2005-08-31
Brief Summary
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In the present study autoregulation of the choroid will be investigated 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 or presence of a NO synthase inhibitor. As a control substance the alpha-receptor agonist phenylephrine will be used.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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1
Phenylephrine (Neosynephrine®, Abbott Laboratories, North Chicago, IL, USA) dose: 1µg/(kg.min), infusion period 20 minutes
Suction cup application
he IOP will be raised by a 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus.
Laser Doppler flowmetry
Measurement of choroidal blood flow
Measurement of intraocular pressure
2
NG-monomethyl-L-arginine (L-NMMA, Clinalfa, Läufelfingen, Switzerland) dose: bolus 6mg/kg over 5 minutes followed by a continuous infusion of 60µg/(kg.min) over 15 minutes
Suction cup application
he IOP will be raised by a 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus.
Laser Doppler flowmetry
Measurement of choroidal blood flow
Measurement of intraocular pressure
3
Physiologic saline solution
Suction cup application
he IOP will be raised by a 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus.
Laser Doppler flowmetry
Measurement of choroidal blood flow
Measurement of intraocular pressure
Interventions
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Suction cup application
he IOP will be raised by a 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus.
Laser Doppler flowmetry
Measurement of choroidal blood flow
Measurement of intraocular pressure
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
* 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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Gabriele Fuchsjäger-Mayrl, 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-270602
Identifier Type: -
Identifier Source: org_study_id