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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT00338065
Other study ID # Vanderbilt IRB# 010436
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 2006
Est. completion date December 2027

Study information

Verified date April 2024
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Postural change
Intraocular pressures, blood pressures, and retinal thicknesses are measured with postural changes
Water drinking
Intraocular pressures, blood pressures, and retinal thicknesses are measured with water drinking.

Locations

Country Name City State
United States Vanderbilt University Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Intraocular Pressure A change in intraocular pressure is measured after change in posture or drinking water. Within 1 day
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