- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00783029
Measurement of the Eye's Blood Vessels Using the Dynamic Vessel Analyzer (DVA)
February 6, 2012 updated by: Kerstin Bettermann, Penn State University
Reproducibility of Dynamic Vessel Analyzer Measurements and Establishment of Standards
The purpose of this research study is examine the response of the blood vessels in the eye to a light flicker stimulus using the Dynamic Vessel Analyzer (DVA) on two separate days in healthy individuals.
The DVA uses an instrument which is used during routine eye examinations.
The hypothesis of the study is that the changes in eye's blood vessel will be similar between the two visits; thus establishing reproducibility of the measurements for future comparisons to individuals with stroke or heart disease.
In addition, this study will compare the eye's blood vessel responses to responses of the blood vessels in the arm using Doppler ultrasound.
Study Overview
Status
Completed
Conditions
Detailed Description
Retinal blood vessels have been suggested to be an index of the cerebral and coronary microvasculature function.
Since the retinal vessels are not under direct sympathetic control, this vascular bed is an ideal location to examine local mechanisms of vascular regulation(i.e.
metabolite/endothelial and myogenic).
Based on previously published data on animal and human responses, the central purpose for the proposed research is to compare the retinal and brachial vasodilatation responses in healthy subjects using the Dynamic Vessel Analyzer (DVA).
Our rationale for this proposal is to better understand retinal blood flow in healthy individuals, gain insight into vascular reactivity in different vascular beds, and lastly to establish standards and reproducibility of DVA Measurements.
Study Type
Observational
Enrollment (Actual)
87
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Milton S. Hershey Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy Subjects
Description
Inclusion Criteria:
- Healthy Individuals
- Age: 21 to 65 years
- Non-smokers
- Non-obese
Exclusion Criteria:
- History of cardiovascular, pulmonary, peripheral vascular disease, renal, prostate, and urinary retention disease; Hypertension; Narrow angle Glaucoma or Age Related Macular Degeneration.
- Pregnancy
- Inability to fixate using eye device
- Does not wish to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy Subjects
Healthy participants between the ages of 21 and 65 years old.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To characterize changes in the diameter of retinal blood vessels to a light-induced flicker stimulus in healthy subjects on two separate visits.
Time Frame: 1 Year
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare retinal vasodilator responses to brachial reactive hyperemic responses.
Time Frame: 1 Year
|
1 Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
October 30, 2008
First Submitted That Met QC Criteria
October 30, 2008
First Posted (Estimate)
October 31, 2008
Study Record Updates
Last Update Posted (Estimate)
February 7, 2012
Last Update Submitted That Met QC Criteria
February 6, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- HMC29113
- IRB # 29113
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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