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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

October 30, 2008
February 6, 2012
October 2008
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00783029 on ClinicalTrials.gov Archive Site
To compare retinal vasodilator responses to brachial reactive hyperemic responses. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Measurement of the Eye's Blood Vessels Using the Dynamic Vessel Analyzer (DVA)
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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Healthy Subjects
Healthy
Not Provided
Healthy Subjects
Healthy participants between the ages of 21 and 65 years old.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00783029
HMC29113, IRB # 29113
No
Kerstin Bettermann, Penn State University
Penn State University
Not Provided
Principal Investigator: Kerstin Bettermann, MD, PhD Penn State College of Medicine
Penn State University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP