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Enrolling by invitationNCT00338065Updated Dec 29, 2025

External Influences Upon Ocular Homeostasis

An interventional study of Postural change and Water drinking in Intraocular Pressure, sponsored by Vanderbilt University Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged 10 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
10 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intraocular Pressure

Keywords

  • Intraocular Pressure
03

In context

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 90 Years
Sexes eligible
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

Exclusion criteria:

  • Medical students
  • Prisoners
  • Pregnant women
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • 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 · Behavioral: 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 · Behavioral: 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 · Behavioral: 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 · Behavioral: Water drinking

Interventions

  • BehavioralPostural change

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

  • BehavioralWater drinking

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

06

What researchers measure

Primary outcomes

  1. Change in Intraocular Pressure

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

    Time frame: Within 1 day

07

Study locations

1 site
  • Vanderbilt University
    Nashville, Tennessee 37232, United States
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References and documents

Publications

  • 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. PubMed 23622564 ↗
  • 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. PubMed 33947782 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00338065
Lead sponsor
Vanderbilt University Medical Center
Responsible party
Karen Joos (Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
Jun 20, 2006
Start date
Jun 2006
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Dec 29, 2025

Study contacts

Karen Joos, MD,PhD
principal investigator · Vanderbilt Eye Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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