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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00452283
First Posted: March 27, 2007
Last Update Posted: January 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose

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.


Condition
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)
  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452283


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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00452283     History of Changes
Other Study ID Numbers: 06-0792
First Submitted: March 23, 2007
First Posted: March 27, 2007
Last Update Posted: January 31, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action