Progressive Open Angle Glaucoma (OAG) and Ocular Blood Flow

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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: June 2, 2009
• First Posted Date: June 3, 2009
• Last Update Posted Date: November 21, 2014
• Study Start Date: May 2007
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (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. ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Progressive Open Angle Glaucoma (OAG) and Ocular Blood Flow
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Open Angle Glaucoma

Intervention

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: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: November 20, 2014): 0
• Original Estimated Enrollment (submitted: June 2, 2009): 200
• Actual Study Completion Date: November 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT00912470
• Other Study ID Numbers: OPHT-020706
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Deparment of clinical pharmacology, Medical university of Vienna
• Study Sponsor: Medical University of Vienna
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gerhard Garhöfer, MD; Department of Clinical Pharmacology, Medical University of Vienna

• PRS Account: Medical University of Vienna
• Verification Date: November 2014