NCT00812526

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 choroid. Choroidal autoregulation was first shown in a rabbit model where intraocular pressure (IOP) and arterial blood pressure could be varied independently. In these experiments regulation of choroidal blood flow was not only dependent on ocular perfusion pressure, but was also dependent on the value of IOP. This indicates that a myogenic mechanism contributes to choroidal autoregulation, because the regulatory capacity is dependent on the transmural pressure. In the model of myogenic autoregulation arterioles change their vascular tone depending on the pressure inside the vessel and outside the vessel. The present experiments are designed to test whether a myogenic mechanism may also be involved in choroidal autoregulation in humans. For this purpose the investigators perform experiments during which the IOP and the arterial blood pressure is increased. According to the myogenic theory of autoregulation one would expect stronger vasoconstriction at lower IOPs for the same increase in ocular perfusion pressure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2002

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
Last Updated

December 22, 2008

Status Verified

December 1, 2008

Enrollment Period

2 years

First QC Date

December 18, 2008

Last Update Submit

December 19, 2008

Conditions

Keywords

ChoroidRegional blood flowAutoregulationLaser Doppler flowmetry

Outcome Measures

Primary Outcomes (1)

  • Relationship between ocular perfusion pressure and choroidal blood flow

    4 study days

Secondary Outcomes (4)

  • Choroidal blood flow

    4 study days

  • Mean arterial pressure

    4 study days

  • Intraocular pressure

    4 study days

  • Systolic/diastolic blood pressure

    4 study days

Interventions

Eligibility Criteria

Age19 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged between 19 and 35 years, nonsmokers
  • Body mass index between 15th and 85th percentile
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropia \< 1 Dpt.

You may not qualify if:

  • 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
  • Blood donation during the previous 3 weeks
  • Presence of intraocular pathology: ocular hypertension, glaucoma, retinal vasculopathy or other retinal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

Study Officials

  • Elzbieta Polska, MD

    Department of Clinical Pharmacology, Medical University of Vienna

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 22, 2008

Study Start

September 1, 2002

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

December 22, 2008

Record last verified: 2008-12

Locations