NCT00338065

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jun 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jun 2006Dec 2027

Study Start

First participant enrolled

June 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
21.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

21.5 years

First QC Date

June 15, 2006

Last Update Submit

December 19, 2025

Conditions

Intraocular Pressure

Keywords

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • Change in Intraocular Pressure

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

    Within 1 day

Study Arms (4)

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.

Behavioral: Postural changeBehavioral: 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.

Behavioral: Postural changeBehavioral: 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.

Behavioral: Postural changeBehavioral: 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.

Behavioral: Postural changeBehavioral: Water drinking

Interventions

Postural changeBEHAVIORAL

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

Normal subjectsPrimary open-angle glaucoma subjectsSubjects with autonomic dysfunctionSubjects with normal-pressure glaucoma
Water drinkingBEHAVIORAL

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

Normal subjectsPrimary open-angle glaucoma subjectsSubjects with autonomic dysfunctionSubjects with normal-pressure glaucoma

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with autonomic dysfunction
  • Patients with open-angle glaucoma
  • Patients with normal-pressure glaucoma
  • Normal subjects

You may not qualify if:

  • Medical students
  • Prisoners
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

  • 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.

    PMID: 23622564RESULT

  • 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.

    PMID: 33947782RESULT

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Karen Joos, MD,PhD

    Vanderbilt Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 20, 2006

Study Start

June 1, 2006

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)