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External Influences Upon Ocular Homeostasis

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ClinicalTrials.gov Identifier: NCT00338065
Recruitment Status : Recruiting
First Posted : June 20, 2006
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Karen Joos, Vanderbilt University Medical Center

Brief Summary:
Our experiments are designed to test the overall hypothesis that position-dependent or water-dependent intra-ocular pressure (IOP) spikes occur in humans, and that these challenge ocular homeostasis.

Condition or disease Intervention/treatment Phase
Intraocular Pressure Behavioral: Postural change Behavioral: Water drinking Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: External Influences Upon Ocular Homeostasis
Study Start Date : June 2006
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Subjects with autonomic dysfunction

Subjects with known autonomic dysfunction diagnoses as defined by the General Clinical Research Center (GCRC) such as pure autonomic failure, Postural orthostatic tachycardia syndrome (POTS), and Multiple System Atrophy( MSA).

  1. Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes
  2. Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.
Behavioral: Postural change
Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes

Behavioral: Water drinking
Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.

Experimental: Primary open-angle glaucoma subjects

Subjects diagnosed with primary open-angle glaucoma following a glaucoma specialist's examination.

  1. Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes
  2. Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.
Behavioral: Postural change
Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes

Behavioral: Water drinking
Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.

Experimental: Subjects with normal-pressure glaucoma

Subjects with open-angle glaucoma damage following a glaucoma specialist's examination without ever an intraocular pressure recording greater than 21 mm Hg.

.1. Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes

2. Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.

Behavioral: Postural change
Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes

Behavioral: Water drinking
Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.

Active Comparator: Normal subjects

Subjects without evidence of glaucoma or autonomic dysfunction.

..1. Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes

2. Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.

Behavioral: Postural change
Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes

Behavioral: Water drinking
Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.




Primary Outcome Measures :
  1. Change in Intraocular Pressure [ Time Frame: Within 1 day ]
    A change in intraocular pressure is measured after change in posture or drinking water.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with autonomic dysfunction
  • Patients with open-angle glaucoma
  • Patients with normal-pressure glaucoma
  • Normal subjects

Exclusion criteria:

  • Medical students
  • Prisoners
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338065


Contacts
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Contact: Karen Joos, MD, PhD 615-936-1957
Contact: Scott Ruark 615-936-1639 scott.ruark@vanderbilt.edu

Locations
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United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Scott Ruark    615-936-1639    scott.ruark@vanderbilt.edu   
Principal Investigator: Karen Joos, MD, PhD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Karen Joos, MD,PhD Vanderbilt Eye Institute

Publications of Results:
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Responsible Party: Karen Joos, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00338065     History of Changes
Other Study ID Numbers: Vanderbilt IRB# 010436
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Karen Joos, Vanderbilt University Medical Center:
Intraocular Pressure