GlaucomaNCT00452283
Changes in Eye Pressure and Anterior Chamber Depth With Oral Endothelin Antagonist Therapy
An observational study of Glaucoma and Pulmonary Hypertension, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glaucoma, Pulmonary Hypertension
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with pulmonary hypertension
Who may be able to join
- diagnosed with pulmonary hypertension
- between the ages of 18 and 80 years
- ability to undergo the various ocular exams.
Who cannot join
- patients with other diseases that could affect the nerve fiber layer
- special populations; ie children, pregnancy, lactating females, prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Eye Center
Aurora, Colorado, 80045
About this study
Official title: 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.
- Conditions
- Glaucoma, Pulmonary Hypertension
- Medical subject headings
- Glaucoma, Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of nerve fiber layer abnormalities
Measured: Single Exam
Secondary outcomes (1)
Optic Nerve Head Structure
Measured: Single Exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malik Y. Kahook, M.D., Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452283
- Sponsor's protocol ID
- 06-0792
- Status last verified
- Jan 2013
- First submitted
- 23 Mar 2007
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Systemic Non-selective Endothelin Antagonist on Intraocular Pressure and Anterior Depth in Pulmonary Hypertension Patients.
- ClinicalTrials.gov ID
- NCT00452283
- Acronym / sponsor ID
- 06-0792
- Conditions
- Glaucoma, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with pulmonary hypertension
Key inclusion criteria (3 listed)
- diagnosed with pulmonary hypertension
- between the ages of 18 and 80 years
- ability to undergo the various ocular exams.
Key exclusion criteria (2 listed)
- patients with other diseases that could affect the nerve fiber layer
- special populations; ie children, pregnancy, lactating females, prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurence of nerve fiber layer abnormalities
Time frame: Single Exam
1 secondary outcome
Optic Nerve Head Structure
Time frame: Single Exam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malik Y. Kahook, M.D. principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Pulmonary Hypertension, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of nerve fiber layer abnormalities (time frame: Single Exam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.