External Influences Upon Ocular Homeostasis

April 9, 2023 updated by: Karen Joos, Vanderbilt University Medical Center
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 88 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intraocular Pressure
Time Frame: Within 1 day
A change in intraocular pressure is measured after change in posture or drinking water.
Within 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Anticipated)

December 1, 2027

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

June 15, 2006

First Submitted That Met QC Criteria

June 15, 2006

First Posted (Estimate)

June 20, 2006

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 9, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Vanderbilt IRB# 010436

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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