Changes in Eye Pressure and Anterior Chamber Depth With Oral Endothelin Antagonist Therapy

Glaucoma Clinical Trial

Official title:

The Effect of a Systemic Non-selective Endothelin Antagonist on Intraocular Pressure and Anterior Depth in Pulmonary Hypertension Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452283
• Other study ID #: 06-0792
• Status: Completed
• Phase: N/A
• First received: March 23, 2007
• Last updated: January 29, 2013
• Start date: March 2007
• Est. completion date: May 2011

Study information

• Verified date: January 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

There is growing evidence that a cause of glaucoma is linked to circulatory problems and poor auto-regulation of blood flow to the optic nerve. Pulmonary hypertension (PH)is a disease characterized by low oxygen levels in the blood and altered blood circulation. The decrease in oxygen delivery to the optic nerve could lead to the loss of nerve fiber layer(NFL)in the retina and the resulting visual field compromise. This situation is characteristic of glaucoma. The ability to identify NFL thinning early could lead to earlier diagnosis of glaucoma and more effective treatment to limit dysfunction from visual field loss.

We hypothesize that the rate of structural damage to the NFL, a feature of glaucoma, is higher in patients with PH than expected in healthy populations lacking this disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• diagnosed with pulmonary hypertension

• between the ages of 18 and 80 years

• ability to undergo the various ocular exams.

Exclusion Criteria:

• patients with other diseases that could affect the nerve fiber layer

• special populations; ie children, pregnancy, lactating females, prisoners

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
United States	University of Colorado Eye Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Field Defects		Single Exam	No
Other	Retinal Blood Flow Changes		Single Exam	No
Primary	Occurence of nerve fiber layer abnormalities		Single Exam	No
Secondary	Optic Nerve Head Structure		Single Exam	No