External Influences Upon Ocular Homeostasis

Intraocular Pressure Clinical Trial

Official title:

External Influences Upon Ocular Homeostasis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00338065
• Other study ID #: Vanderbilt IRB# 010436
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Intraocular Pressure

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