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Correlation of Optic Disk Morphology and Ocular Perfusion Parameters in Patients With Primary Open Angle Glaucoma

Primary Purpose

Primary Open Angle Glaucoma

Status
Completed
Phase
Locations
Austria
Study Type
Observational
Intervention
ocular blood flow measurement
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Primary Open Angle Glaucoma focused on measuring optic disc morphology, ocular blood flow, retina, ocular physiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deparmtent of Clinical Pharmacology

Outcomes

Primary Outcome Measures

Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry)
Retinal blood flow (scanning laser Doppler flowmetry, laser Doppler velocimetry + retinal vessel analyzer)
Choroidal blood flow (laser Doppler flowmetry, laser interferometry, pneumotonometry)
Optic nerve head morphology parameters
Fundus photography: evaluation based on Jonas et al. 2003 J Glaucoma 12:260-265,
Heidelberg Retina Tomograph: evaluation based on Iester et al. 2001 Am J Ophthalmol 132: 57-62,

Secondary Outcome Measures

Full Information

First Posted
December 3, 2008
Last Updated
December 4, 2008
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00803504
Brief Title
Correlation of Optic Disk Morphology and Ocular Perfusion Parameters in Patients With Primary Open Angle Glaucoma
Official Title
Correlation of Optic Disk Morphology and Ocular Perfusion Parameters in Patients With Primary Open Angle Glaucoma
Study Type
Observational

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
optic disc morphology, ocular blood flow, retina, ocular physiology

7. Study Design

Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
ocular blood flow measurement
Primary Outcome Measure Information:
Title
Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry)
Title
Retinal blood flow (scanning laser Doppler flowmetry, laser Doppler velocimetry + retinal vessel analyzer)
Title
Choroidal blood flow (laser Doppler flowmetry, laser interferometry, pneumotonometry)
Title
Optic nerve head morphology parameters
Title
Fundus photography: evaluation based on Jonas et al. 2003 J Glaucoma 12:260-265,
Title
Heidelberg Retina Tomograph: evaluation based on Iester et al. 2001 Am J Ophthalmol 132: 57-62,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhöfer, MD
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deparmtent of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Correlation of Optic Disk Morphology and Ocular Perfusion Parameters in Patients With Primary Open Angle Glaucoma

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