NCT00783029

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

3.2 years

First QC Date

October 30, 2008

Last Update Submit

February 6, 2012

Conditions

Healthy

Keywords

VasodilationVessel ReactivityDynamic Vessel AnalyzerRetina

Outcome Measures

Primary Outcomes (1)

  • To characterize changes in the diameter of retinal blood vessels to a light-induced flicker stimulus in healthy subjects on two separate visits.

    1 Year

Secondary Outcomes (1)

  • To compare retinal vasodilator responses to brachial reactive hyperemic responses.

    1 Year

Study Arms (1)

Healthy Subjects

Healthy participants between the ages of 21 and 65 years old.

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy Subjects

You may qualify if:

  • Healthy Individuals
  • Age: 21 to 65 years
  • Non-smokers
  • Non-obese

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kerstin Bettermann, MD, PhD

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 30, 2008

First Posted

October 31, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations

US(1)