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Role of Nitrogen Oxide (NO) in the Control of Choroidal Blood Flow During a Decrease in Ocular Perfusion Pressure

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Medical University of Vienna

Status and phase

Completed
Phase 2

Conditions

Regional Blood Flow
Autoregulation
Physiology, Ocular
Microcirculation

Treatments

Procedure: Measurement of intraocular pressure
Procedure: Laser Doppler flowmetry
Procedure: Suction cup application

Study type

Interventional

Funder types

Other

Identifiers

NCT00810927
OPHT-270602

Details and patient eligibility

About

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.

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.

Enrollment

22 patients

Sex

Male

Ages

19 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Men aged between 19 and 35 years, nonsmokers
  • 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

  • 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
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

22 participants in 3 patient groups, including a placebo group

1
Active Comparator group
Description:
Phenylephrine (Neosynephrine®, Abbott Laboratories, North Chicago, IL, USA) dose: 1µg/(kg.min), infusion period 20 minutes
Treatment:
Procedure: Laser Doppler flowmetry
Procedure: Suction cup application
Procedure: Measurement of intraocular pressure
2
Active Comparator group
Description:
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
Treatment:
Procedure: Laser Doppler flowmetry
Procedure: Suction cup application
Procedure: Measurement of intraocular pressure
3
Placebo Comparator group
Description:
Physiologic saline solution
Treatment:
Procedure: Laser Doppler flowmetry
Procedure: Suction cup application
Procedure: Measurement of intraocular pressure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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