External Influences Upon Ocular Homeostasis

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT00338065
Collaborator
(none)
200
1
4
258
0.8

Study Details

Study Description

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
  • Behavioral: Postural change
  • Behavioral: Water drinking
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2006
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Intraocular Pressure [Within 1 day]

    A change in intraocular pressure is measured after change in posture or drinking water.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Nashville Tennessee United States 37232

Sponsors and Collaborators

  • Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Karen Joos, MD,PhD, Vanderbilt Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karen Joos, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00338065
Other Study ID Numbers:
  • Vanderbilt IRB# 010436
First Posted:
Jun 20, 2006
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Karen Joos, Professor, Vanderbilt University Medical Center

Study Results

No Results Posted as of Apr 7, 2022