Measurement of the Eye's Blood Vessels Using the Dynamic Vessel Analyzer (DVA)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kerstin Bettermann, Penn State University

ClinicalTrials.gov Identifier:

NCT00783029

First received: October 30, 2008

Last updated: February 6, 2012

Last verified: February 2012

History of Changes

Purpose

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.

Condition
Healthy


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Reproducibility of Dynamic Vessel Analyzer Measurements and Establishment of Standards

Further study details as provided by Penn State University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare retinal vasodilator responses to brachial reactive hyperemic responses. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]


Enrollment:	87
Study Start Date:	October 2008
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Healthy Subjects Healthy participants between the ages of 21 and 65 years old.

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.

Eligibility


Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy Subjects

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783029

Locations


United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators

Penn State University

Investigators


Principal Investigator:	Kerstin Bettermann, MD, PhD	Penn State College of Medicine

More Information

No publications provided


Responsible Party:	Kerstin Bettermann, MD, PhD, Penn State University
ClinicalTrials.gov Identifier:	NCT00783029 History of Changes
Other Study ID Numbers:	HMC29113, IRB # 29113
Study First Received:	October 30, 2008
Last Updated:	February 6, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Penn State University:


Vasodilation Vessel Reactivity Dynamic Vessel Analyzer Retina

ClinicalTrials.gov processed this record on February 27, 2015

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