Mechanisms of Choroidal Blood Flow Changes During Dark/Light Transitions

NCT ID: NCT00431392

Last Updated: 2007-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30

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.

Conditions

Regional Blood Flow; Ocular Physiology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Phenylephrine

Intervention Type: DRUG

NG-Monomethyl-L-Arginine

Intervention Type: DRUG

Propanolol

Intervention Type: DRUG

Atropine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Principal Investigators

Michael Wolzt, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

OPHT-180601

Identifier Type: -

Identifier Source: org_study_id