- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00803504
Correlation of Optic Disk Morphology and Ocular Perfusion Parameters in Patients With Primary Open Angle Glaucoma
December 4, 2008 updated by: Medical University of Vienna
Glaucoma is one of the most common causes of blindness in the industrialized nations.
For a long time glaucoma has been defined as a disease in which high intraocular pressure (IOP) leads to irreversible optic disc damage and subsequent visual field loss.
However, recent investigations show that IOP is not the only factor that is involved in the glaucomatous process leading to retinal ganglion cell death.
The role of vascular factors in the pathogenesis of glaucoma has recently received much attention based on animal experiments and epidemiological studies.
It is, however, assumed that vascular factors do not contribute to same degree in all glaucoma patients.
Generally, it is believed that a vascular component is more important in normal tension glaucoma patients and patients with underlying cardiovascular disease.
Little is, however, known about a potential association between optic nerve head morphology and ocular perfusion in POAG patients.
The current study seeks to gain insight into this association by assessing ocular blood flow parameters with a number of noninvasive technologies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
103
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, 1090
- Deparmtent of Clinical Pharmacology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women over 18 years
- Unilateral or bilateral primary open angle glaucoma
- At least 3 reliable visual field tests showing CPSD >= 2.0 in the eye that will be studied
Exclusion Criteria:
- History of acute angle closure
- Closed or barely open anterior chamber angle
- Standard deviation of visual field testing > 10
- Intraocular surgery or argon laser trabeculoplasty within the last six months
- Ocular inflammation or infection within the last three months
- Topical or systemically/oral therapy with steroids
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry)
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Retinal blood flow (scanning laser Doppler flowmetry, laser Doppler velocimetry + retinal vessel analyzer)
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Choroidal blood flow (laser Doppler flowmetry, laser interferometry, pneumotonometry)
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Optic nerve head morphology parameters
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Fundus photography: evaluation based on Jonas et al. 2003 J Glaucoma 12:260-265,
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Heidelberg Retina Tomograph: evaluation based on Iester et al. 2001 Am J Ophthalmol 132: 57-62,
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
December 3, 2008
First Submitted That Met QC Criteria
December 4, 2008
First Posted (Estimate)
December 5, 2008
Study Record Updates
Last Update Posted (Estimate)
December 5, 2008
Last Update Submitted That Met QC Criteria
December 4, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPHT-120905
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.