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

This study has been completed.
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: March 23, 2007
Last updated: January 29, 2013
Last verified: January 2013

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.

Glaucoma Pulmonary Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of a Systemic Non-selective Endothelin Antagonist on Intraocular Pressure and Anterior Depth in Pulmonary Hypertension Patients.

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Occurence of nerve fiber layer abnormalities [ Time Frame: Single Exam ]

Secondary Outcome Measures:
  • Optic Nerve Head Structure [ Time Frame: Single Exam ]

Other Outcome Measures:
  • Visual Field Defects [ Time Frame: Single Exam ]
  • Retinal Blood Flow Changes [ Time Frame: Single Exam ]

Enrollment: 23
Study Start Date: March 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with pulmonary hypertension

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00452283

United States, Colorado
University of Colorado Eye Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Principal Investigator: Malik Y. Kahook, M.D. University of Colorado School of Medicine
  More Information

Responsible Party: University of Colorado, Denver Identifier: NCT00452283     History of Changes
Other Study ID Numbers: 06-0792
Study First Received: March 23, 2007
Last Updated: January 29, 2013

Additional relevant MeSH terms:
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017