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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

March 23, 2007
January 29, 2013
March 2007
May 2011   (final data collection date for primary outcome measure)
Occurence of nerve fiber layer abnormalities [ Time Frame: Single Exam ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00452283 on ClinicalTrials.gov Archive Site
Optic Nerve Head Structure [ Time Frame: Single Exam ] [ Designated as safety issue: No ]
Not Provided
  • 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 ]
Not Provided
 
Changes in Eye Pressure and Anterior Chamber Depth With Oral Endothelin Antagonist Therapy
The Effect of a Systemic Non-selective Endothelin Antagonist on Intraocular Pressure and Anterior Depth in Pulmonary Hypertension Patients.

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Patients diagnosed with pulmonary hypertension
  • Glaucoma
  • Pulmonary Hypertension
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00452283
06-0792
No
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Malik Y. Kahook, M.D. University of Colorado School of Medicine
University of Colorado, Denver
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP