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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00452283
First received: March 23, 2007
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Occurence of nerve fiber layer abnormalities [ Time Frame: Single Exam ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Optic Nerve Head Structure [ Time Frame: Single Exam ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Visual Field Defects [ Time Frame: Single Exam ] [ Designated as safety issue: No ]
  • Retinal Blood Flow Changes [ Time Frame: Single Exam ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00452283     History of Changes
Other Study ID Numbers: 06-0792
Study First Received: March 23, 2007
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Hypertension
Hypertension, Pulmonary
Ocular Hypertension
Eye Diseases
 Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013