Progressive Open Angle Glaucoma (OAG) and Ocular Blood Flow

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Medical University of Vienna.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00912470
First received: June 2, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Open Angle Glaucoma
Regional Blood Flow
Procedure: ocular blood flow measurement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Genetic Vascular Risk Factors and Ocular Blood Flow in Patients With Progressive Open Angle Glaucoma (OAG)-a Longitudinal Prospective Study

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry). [ Time Frame: Ocular blood flow parameters will be assesed once on each study day. 12 study days are scheduled every 6 months for 6 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2007
Estimated Study Completion Date: July 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: ocular 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

    Other Name: Blood sample for Frequency distribution of alleles
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912470

Locations
Austria
Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Garhöfer, MD Department of Clinical Pharmacology, Medical University of Vienna
  More Information

No publications provided

Responsible Party: Deparment of clinical pharmacology, Medical university of Vienna
ClinicalTrials.gov Identifier: NCT00912470     History of Changes
Other Study ID Numbers: OPHT-020706
Study First Received: June 2, 2009
Last Updated: June 2, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
genetic vascular risc factors
ocular blood flow
progressive glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on October 23, 2014