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External Influences Upon Ocular Homeostasis
This study is currently recruiting participants.
Verified by Vanderbilt University, November 2008
Sponsored by: Vanderbilt University
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00338065
  Purpose

Our experiments are designed to test the overall hypothesis that position-dependent IOP spikes occur in humans, and that these challenge ocular homeostasis.


Condition
Intraocular Pressure

U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: External Influences Upon Ocular Homeostasis

Further study details as provided by Vanderbilt University:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 100
Study Start Date: June 2006
Estimated Study Completion Date: December 2009
Detailed Description:

Glaucoma is the second leading cause of blindness in the United States, yet its pathogenesis is poorly understood. This is an insidious disorder since the loss of peripheral vision which occurs first usually is not noticed by the victim. Approximately 1 million people in the United States have glaucoma, but are not aware of it. Glaucoma is not always associated with elevated intraocular pressures so that vision screenings which measure just intraocular pressure without assessing the optic nerve will also miss these patients with glaucomatous damage. Therefore, patients are often diagnosed only when they have severe irreversible vision loss. Vascular insufficiency or abnormal autoregulation versus mechanical pressure damage has been proposed as a major factor in the development of glaucoma. Presently, therapy is based upon lowering intraocular pressure. If a contributing intermittent pressure elevation factor can be elucidated and characterized, specific treatment modalities may then be developed and their effectiveness can be monitored.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The main purpose of this study is to find out the importance of the involuntary (autonomic) nervous system, blood pressure in the arteries and the veins, postural position, and externally applied pressure on the functions of the eye.

involuntary (autonomic) nervous system, blood pressure in the arteries and the

Criteria

Inclusion Criteria:

  • Non child-bearing subjects

Exclusion criteria:

  • Medical students
  • Child-bearing age women
  • Subjects on glaucoma medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338065

Contacts
Contact: Karen Joos, MD 615-936-2020
Contact: Sandy Owings, COA 615-936-3465 sandy.owings@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sandy Owings, COA     615-936-3465     Sandy.owings@vanderbilt.edu    
Principal Investigator: Karen Joos, MD            
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Karen Joos, MD Vanderbilt Eye Institute
  More Information

Responsible Party: Karen Joos, MD, Ph.D ( Karen Joos, MD, Ph.D )
Study ID Numbers: Vanderbilt IRB# 010436
Study First Received: June 15, 2006
Last Updated: November 4, 2008
ClinicalTrials.gov Identifier: NCT00338065  
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Intraocular Pressure

ClinicalTrials.gov processed this record on January 14, 2009