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External Influences Upon Ocular Homeostasis

NCT ID: NCT00338065

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intraocular Pressure

Keywords

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Intraocular Pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Postural change

Intervention Type BEHAVIORAL

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

Water drinking

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Postural change

Intervention Type BEHAVIORAL

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

Water drinking

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Postural change

Intervention Type BEHAVIORAL

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

Water drinking

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Postural change

Intervention Type BEHAVIORAL

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

Water drinking

Intervention Type BEHAVIORAL

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

Interventions

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Postural change

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

Intervention Type BEHAVIORAL

Water drinking

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Karen Joos

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Joos, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Eye Institute

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Phillips L, Robertson D, Melson MR, Garland EM, Joos KM. Pediatric ptosis as a sign of treatable autonomic dysfunction. Am J Ophthalmol. 2013 Aug;156(2):370-374.e2. doi: 10.1016/j.ajo.2013.03.009. Epub 2013 Apr 24.

Reference Type RESULT
PMID: 23622564 (View on PubMed)

Shibao CA, Joos K, Phillips JA 3rd, Cogan J, Newman JH, Hamid R, Meiler J, Capra J, Sheehan J, Vetrini F, Yang Y, Black B, Diedrich A, Roberston D, Biaggioni I. Familial Autonomic Ganglionopathy Caused by Rare CHRNA3 Genetic Variants. Neurology. 2021 Jul 13;97(2):e145-e155. doi: 10.1212/WNL.0000000000012143. Epub 2021 May 4.

Reference Type RESULT
PMID: 33947782 (View on PubMed)

Other Identifiers

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Vanderbilt IRB# 010436

Identifier Type: -

Identifier Source: org_study_id