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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00803504
Other study ID # OPHT-120905
Secondary ID
Status Completed
Phase N/A
First received December 3, 2008
Last updated December 4, 2008
Start date November 2006
Est. completion date August 2007

Study information

Verified date December 2008
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

N/A


Intervention

Procedure:
ocular blood flow measurement


Locations

Country Name City State
Austria Deparmtent of Clinical Pharmacology Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry) No
Primary Retinal blood flow (scanning laser Doppler flowmetry, laser Doppler velocimetry + retinal vessel analyzer) No
Primary Choroidal blood flow (laser Doppler flowmetry, laser interferometry, pneumotonometry) No
Primary Optic nerve head morphology parameters No
Primary Fundus photography: evaluation based on Jonas et al. 2003 J Glaucoma 12:260-265, No
Primary Heidelberg Retina Tomograph: evaluation based on Iester et al. 2001 Am J Ophthalmol 132: 57-62, No
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