- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00912470
Progressive Open Angle Glaucoma (OAG) and Ocular Blood Flow
November 20, 2014 updated by: Medical University of Vienna
Genetic Vascular Risk Factors and Ocular Blood Flow in Patients With Progressive Open Angle Glaucoma (OAG)-a Longitudinal Prospective Study
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, 1090
- Department of Clinical Pharmacology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry).
Time Frame: up to 6 years.
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up to 6 years.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (ACTUAL)
November 1, 2014
Study Completion (ACTUAL)
November 1, 2014
Study Registration Dates
First Submitted
June 2, 2009
First Submitted That Met QC Criteria
June 2, 2009
First Posted (ESTIMATE)
June 3, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
November 21, 2014
Last Update Submitted That Met QC Criteria
November 20, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPHT-020706
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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