Mechanisms of Choroidal Blood Flow Changes During Dark/Light Transitions

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT00431392
Collaborator
(none)
42
1

Study Details

Study Description

Brief Summary

There is evidence from a variety of animal studies that choroidal blood flow is under neural control. By contrast, only little information is available from human studies. Recent results indicate that a light/dark transition is associated with a short lasting reduction in choroidal blood flow. We have shown that during unilateral dark/light transition both eyes react with choroidal vasoconstriction strongly indicating a neural mechanism.

The present studies investigate this possibility by using pharmacological interventions. The pharmacological agents tested include a nitric oxide synthase inhibitor, an alpha-receptor agonist (as a control substance for the blood pressure increasing nitric oxide synthase inhibitor), a muscarinic receptor blocker, and a non-specific beta-blocker. These drugs were chosen on the basis of previous animal experiments, as the systems, which are specifically influenced by these substances, are likely involved in neural control of choroidal blood flow.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Mechanisms of Choroidal Blood Flow Changes During Dark/Light Transitions
Study Start Date :
Sep 1, 2001

Outcome Measures

Primary Outcome Measures

  1. choroidal blood flow []

  2. fundus pulsation amplitude []

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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, ametropy < 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:
NCT00431392
Other Study ID Numbers:
  • OPHT-180601
First Posted:
Feb 5, 2007
Last Update Posted:
Feb 5, 2007
Last Verified:
Jan 1, 2007

Study Results

No Results Posted as of Feb 5, 2007