Intraocular PressureNCT00338065
External Influences Upon Ocular Homeostasis
A study testing Postural change and Water drinking in people with Intraocular Pressure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 10 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Postural change and Water drinking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with autonomic dysfunction
- Patients with open-angle glaucoma
- Patients with normal-pressure glaucoma
- Normal subjects
Who cannot join
- Medical students
- Prisoners
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Intraocular Pressure
- Being tested
- Postural change, Water drinking
- Keywords
- Intraocular Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural changeBehavioural
Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes
Water drinkingBehavioural
Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with autonomic dysfunction | Experimental | 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. Receives: Behavioral: Postural change; Behavioral: Water drinking |
| Primary open-angle glaucoma subjects | Experimental | 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. Receives: Behavioral: Postural change; Behavioral: Water drinking |
| Subjects with normal-pressure glaucoma | Experimental | 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. Receives: Behavioral: Postural change; Behavioral: Water drinking |
| Normal subjects | Active comparator | 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. Receives: Behavioral: Postural change; Behavioral: Water drinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure
A change in intraocular pressure is measured after change in posture or drinking water.
Measured: Within 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Joos, Vanderbilt University Medical Center
- Investigators
- Karen Joos, MD,PhD, Principal investigator, Vanderbilt Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338065
- Sponsor's protocol ID
- Vanderbilt IRB# 010436
- Status last verified
- Dec 2025
- First submitted
- 15 Jun 2006
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 23622564Shibao 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Influences Upon Ocular Homeostasis
- ClinicalTrials.gov ID
- NCT00338065
- Acronym / sponsor ID
- Vanderbilt IRB# 010436
- Conditions
- Intraocular Pressure
- Keywords
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects with autonomic dysfunction | Experimental | Behavioral: Postural change, Behavioral: Water drinkingSubjects 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. |
| Primary open-angle glaucoma subjects | Experimental | Behavioral: Postural change, Behavioral: Water drinkingSubjects 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. |
| Subjects with normal-pressure glaucoma | Experimental | Behavioral: Postural change, Behavioral: Water drinkingSubjects 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. |
| Normal subjects | Active comparator | Behavioral: Postural change, Behavioral: Water drinkingSubjects 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. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with autonomic dysfunction
- Patients with open-angle glaucoma
- Patients with normal-pressure glaucoma
- Normal subjects
Key exclusion criteria (3 listed)
- Medical students
- Prisoners
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postural changeIntraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes | Behavioural | Normal subjects, Primary open-angle glaucoma subjects, Subjects with autonomic dysfunction, Subjects with normal-pressure glaucoma |
| Water drinkingIntraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking. | Behavioural | Normal subjects, Primary open-angle glaucoma subjects, Subjects with autonomic dysfunction, Subjects with normal-pressure glaucoma |
Primary outcome
Change in Intraocular Pressure
Time frame: Within 1 day
A change in intraocular pressure is measured after change in posture or drinking water.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Results publication: PubMed 23622564Phillips 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.
- Results publication: PubMed 33947782Shibao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Joos, MD,PhD principal investigator
Vanderbilt Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postural change and Water drinking in people with Intraocular Pressure, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intraocular Pressure (time frame: Within 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00338065, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.