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Progressive Open Angle Glaucoma (OAG) and Ocular Blood Flow

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ClinicalTrials.gov Identifier: NCT00912470
Recruitment Status : Withdrawn
First Posted : June 3, 2009
Last Update Posted : November 21, 2014
Sponsor:
Information provided by:
Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE June 2, 2009
First Posted Date  ICMJE June 3, 2009
Last Update Posted Date November 21, 2014
Study Start Date  ICMJE May 2007
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry). [ Time Frame: up to 6 years. ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
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. ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Progressive Open Angle Glaucoma (OAG) and Ocular Blood Flow
Official Title  ICMJE Genetic Vascular Risk Factors and Ocular Blood Flow in Patients With Progressive Open Angle Glaucoma (OAG)-a Longitudinal Prospective Study
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Open Angle Glaucoma
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 20, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2009)
200
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00912470
Other Study ID Numbers  ICMJE OPHT-020706
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deparment of clinical pharmacology, Medical university of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gerhard Garhöfer, MD Department of Clinical Pharmacology, Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP