Role of Adenosine in the Control of Choroidal Blood Flow During Changes in Ocular Perfusion Pressure.

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT00712764
Collaborator
(none)
20
1
2
3
6.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Role of Adenosine in the Control of Choroidal Blood Flow During Changes in Ocular Perfusion Pressure.
Study Start Date :
Jan 1, 2005
Actual Primary Completion Date :
Apr 1, 2005
Actual Study Completion Date :
Apr 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Drug: Adenosine

Placebo Comparator: 2

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. choroidal pressure-flow relationship [2 hours at 2 study days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Men aged between 18 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Clinical Pharmacology, Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Michael Wolzt, MD, Department of Clinical Pharmacology, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00712764
Other Study ID Numbers:
  • OPHT-011206
First Posted:
Jul 10, 2008
Last Update Posted:
Jul 10, 2008
Last Verified:
Dec 1, 2006
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 10, 2008