- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01663883
Optic Nerve Head Autoregulation During Changes in Arterial Blood Pressure
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1090
- Department of Clinical Pharmacology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
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 (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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy subjects
|
use of a handgrip for 3x2 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Optic nerve head blood flow
Time Frame: 12 minutes
|
12 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Systolic/diastolic blood pressure
Time Frame: 14 minutes
|
14 minutes
|
Intraocular pressure
Time Frame: at baseline and minute 13
|
at baseline and minute 13
|
Pulse rate
Time Frame: 14 minutes
|
14 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OPHT-210911
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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