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WithdrawnNCT00912470Updated Nov 21, 2014

Progressive Open Angle Glaucoma (OAG) and Ocular Blood Flow

An interventional study of ocular blood flow measurement in Open Angle Glaucoma, sponsored by Medical University of Vienna. Withdrawn at 1 site in Austria. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2014-11-21.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
40 Years and older
Sex
All
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Study summary

The purpose of this study is to assess the correlation of vascular parameters, including genetic factors as well as ocular blood flow parameters against the progression rate of glaucomatous damage in patients with progressive OAG.

Read the detailed description

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. Genes with products that are involved in the regulation of blood flow to ocular tissues may also be considered plausible candidates as a contributory factor in the development of glaucoma. Little is, however, known about a potential association between glaucomatous optic neuropathy and glaucomatous visual field defects and optic nerve head blood flow in patients with progressive open angle glaucoma (OAG). The current study seeks to gain insight into this association by assessing ocular blood flow parameters with a number of noninvasive technologies.

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Conditions studied

  • Open Angle Glaucoma

Keywords

  • genetic vascular risc factors
  • ocular blood flow
  • progressive glaucoma
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In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

Browse Glaucoma studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men and women over 40 years
  • Unilateral or bilateral primary open angle glaucoma (POAG) or normal tension glaucoma (NTG) with visual defect, marked by an AGIS score (1994; 1. Study design and methods and baseline characteristics of study patient) of at least 1 but not more than 16 at the screening visit
  • At least 3 reliable visual field tests in the eye that will be studied
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Best-corrected visual acuity of 20/40 or better, spherical refraction within ± 3.0 diopters and cylinder correction within ± 3.0 diopters

Exclusion criteria

Exclusion Criteria:

  • Evidence of secondary glaucoma, pseudoexfoliation, pigmentary dispersion
  • Any form of retinal or neuroophthalmological disease that could result in visual field defects.
  • Mean IOP > 30 mmHg, or any IOP > 35 mmHg in at least one eye
  • History of acute angle closure
  • Closed or barely open anterior chamber angle
  • Topical or systemical/oral therapy with steroids
  • Standard deviation of visual field testing > 10
  • Ocular inflammation or infection within the last three months
  • Intraocular surgery or argon laser trabeculoplasty within the last six months
  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Treatment in the previous 3 weeks with any drug
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Blood donation during the previous 3 weeks
  • Ametropia > 3 dpt
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • Procedureocular blood flow measurement

    Retinal blood flow (with scanning laser Doppler flowmetry, laser Doppler velocimetry + retinal vessel analyzer) each measurement once on the study eye Choroidal blood flow (with laser Doppler flowmetry, laser interferometry, pneumotonometry) Frequency distribution of alleles of genetic markers for NOS3, more precisely eNOS -786CC polymorphism and of ET-1 (EDN1), and the receptors ETA (EDNRA), more precisely EDN1/+138/ex1 del/ins, EDN1/K198N, EDNRA/C+1222T, EDNRA/C+70G polymorphisms

    Also known as: Blood sample for Frequency distribution of alleles

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What researchers measure

Primary outcomes

  1. Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry).

    Time frame: up to 6 years.

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Study locations

1 site
  • Department of Clinical Pharmacology
    Vienna, 1090, Austria
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00912470
Lead sponsor
Medical University of Vienna
First posted
Jun 3, 2009
Start date
May 2007
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Nov 21, 2014

Study contacts

Gerhard Garhöfer, MD
principal investigator · Department of Clinical Pharmacology, Medical University of Vienna

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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