NCT00803504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
Last Updated

December 5, 2008

Status Verified

December 1, 2008

First QC Date

December 3, 2008

Last Update Submit

December 4, 2008

Conditions

Keywords

optic disc morphologyocular blood flowretinaocular physiology

Outcome Measures

Primary Outcomes (6)

  • 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,

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deparmtent of Clinical Pharmacology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Gerhard Garhöfer, MD

    Department of Clinical Pharmacology, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2008

First Posted

December 5, 2008

Study Start

November 1, 2006

Study Completion

August 1, 2007

Last Updated

December 5, 2008

Record last verified: 2008-12

Locations