Primary Open Angle GlaucomaNCT00803504
Correlation of Optic Disk Morphology and Ocular Perfusion Parameters in Patients With Primary Open Angle Glaucoma
An observational study of Primary Open Angle Glaucoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- ocular blood flow measurement
- Type of treatment
- Surgery or procedure
- How many people
- 103 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2006to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 18 years
- Unilateral or bilateral primary open angle glaucoma
- At least 3 reliable visual field tests showing CPSD >= 2.0 in the eye that will be studied
Who cannot join
- History of acute angle closure
- Closed or barely open anterior chamber angle
- Standard deviation of visual field testing > 10
- Intraocular surgery or argon laser trabeculoplasty within the last six months
- Ocular inflammation or infection within the last three months
- Topical or systemically/oral therapy with steroids
Trial locations and contacts
1 site in 1 country.
About this study
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. It is, however, assumed that vascular factors do not contribute to same degree in all glaucoma patients. Generally, it is believed that a vascular component is more important in normal tension glaucoma patients and patients with underlying cardiovascular disease. Little is, however, known about a potential association between optic nerve head morphology and ocular perfusion in POAG patients. The current study seeks to gain insight into this association by assessing ocular blood flow parameters with a number of noninvasive technologies.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- ocular blood flow measurement
- Keywords
- optic disc morphology, ocular blood flow, retina, ocular physiology
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ocular blood flow measurementProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry)
Retinal blood flow (scanning laser Doppler flowmetry, laser Doppler velocimetry + retinal vessel analyzer)
Choroidal blood flow (laser Doppler flowmetry, laser interferometry, pneumotonometry)
Optic nerve head morphology parameters
Fundus photography: evaluation based on Jonas et al. 2003 J Glaucoma 12:260-265,
Heidelberg Retina Tomograph: evaluation based on Iester et al. 2001 Am J Ophthalmol 132: 57-62,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startNov 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Gerhard Garhöfer, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803504
- Sponsor's protocol ID
- OPHT-120905
- Status last verified
- Dec 2008
- First submitted
- 3 Dec 2008
- Last updated
- 5 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Optic Disk Morphology and Ocular Perfusion Parameters in Patients With Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00803504
- Acronym / sponsor ID
- OPHT-120905
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- optic disc morphology, ocular blood flow, retina, ocular physiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. It is, however, assumed that vascular factors do not contribute to same degree in all glaucoma patients. Generally, it is believed that a vascular component is more important in normal tension glaucoma patients and patients with underlying cardiovascular disease. Little is, however, known about a potential association between optic nerve head morphology and ocular perfusion in POAG patients. The current study seeks to gain insight into this association by assessing ocular blood flow parameters with a number of noninvasive technologies.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women over 18 years
- Unilateral or bilateral primary open angle glaucoma
- At least 3 reliable visual field tests showing CPSD >= 2.0 in the eye that will be studied
Key exclusion criteria (6 listed)
- History of acute angle closure
- Closed or barely open anterior chamber angle
- Standard deviation of visual field testing > 10
- Intraocular surgery or argon laser trabeculoplasty within the last six months
- Ocular inflammation or infection within the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ocular blood flow measurement | Procedure or surgery | – |
Primary outcome
Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry)
Retinal blood flow (scanning laser Doppler flowmetry, laser Doppler velocimetry + retinal vessel analyzer)
Choroidal blood flow (laser Doppler flowmetry, laser interferometry, pneumotonometry)
Optic nerve head morphology parameters
Fundus photography: evaluation based on Jonas et al. 2003 J Glaucoma 12:260-265,
Heidelberg Retina Tomograph: evaluation based on Iester et al. 2001 Am J Ophthalmol 132: 57-62,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Garhöfer, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2008.