Optic Nerve Head Autoregulation During Changes in Arterial Blood Pressure
1 other identifier
interventional
40
1 country
1
Brief Summary
Constant despite changes in perfusion pressure. It is observed in many vascular beds of the human body to prevent that variations in perfusion pressure are directly transmitted into changes in blood flow. This is necessary to prevent ischemia and/or hypoxia during decreased blood flow and bleeding or increased capillary pressure during increased blood flow. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. Unfortunately only few data are available for the optic nerve head. To gain data about autoregulation is of special importance given that several important ocular diseases such as glaucoma and age-related macular degeneration are associated with impaired autoregulation. In humans most data were collected using laser Doppler flowmetry. The present study aims to investigate the phenomenon of transient reduction in blood flow and to gain insight in the regulatory mechanisms of optic nerve head blood flow during isometric exercise.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2012
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
January 24, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 13, 2012
CompletedAugust 13, 2012
August 1, 2012
2 months
January 24, 2012
August 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Optic nerve head blood flow
12 minutes
Secondary Outcomes (3)
Systolic/diastolic blood pressure
14 minutes
Intraocular pressure
at baseline and minute 13
Pulse rate
14 minutes
Study Arms (1)
Healthy subjects
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Men and women aged between 18 and 35 years, nonsmokers
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropia less than 3 diopters
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 (except oral contraceptives)
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Clinical Pharmacology
Vienna, Vienna, 1090, Austria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard Garhöfer, MD
Department of Clinical Pharmacology, Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass. Prof. Priv. Doz. Dr.
Study Record Dates
First Submitted
January 24, 2012
First Posted
August 13, 2012
Study Start
February 1, 2012
Primary Completion
April 1, 2012
Study Completion
August 1, 2012
Last Updated
August 13, 2012
Record last verified: 2012-08