GlaucomaNCT00811694
Neurovascular Coupling in Patients With Open Angle Glaucoma
An observational study of Glaucoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
A variety of studies demonstrate that ocular blood flow is altered in glaucoma. Various animal and human studies have shown an increase in retinal and optic nerve head blood flow in response to diffuse luminance flicker. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- ocular blood flow measurements
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2006to May 2012
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged between 20 and 80 years.
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
- Men and women will be included in equal parts. A pregnancy test will be performed at screening.
- Ametropia of less than 3 diopters and anisometropia of less than 1 diopter.
Who cannot join
- Treatment with vasoactive drugs.
- Presence of intraocular pathology other than open angle glaucoma.
- Presence of ocular hypertension or PEX (pseudoexfoliation) glaucoma
- History or family history of epilepsy.
- Pregnancy.
- Diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Meical University of Vienna, Austria
Vienna, 1090
About this study
A variety of studies demonstrate that ocular blood flow is altered in glaucoma. Various animal and human studies have shown an increase in retinal and optic nerve head blood flow in response to diffuse luminance flicker. Based on studies with ERG, this effect has been attributed to augmented activity in the retinal ganglion cells and associated axons indicating a coupling mechanism between neuronal activity and retinal blood flow. Whereas a variety of studies have confirmed these effects, the knowledge about this coupling in the retina of patients with glaucoma is sparse.
Recently the investigators could show that flicker induced vasodilatation is blunted in patients with open angle glaucoma. However, the investigators results are limited by the fact that only data about retinal vessel diameters, not blood flow per se, are available. The further development of the investigators current flicker stimulation technique now allows us to determine blood flow velocity during flicker stimulation. Thus, in the current study, the investigators set out to determine whether this blood flow response is impaired in patients with glaucoma as compared to those in healthy volunteers and whether this is related to altered neural activity.
The study objective was, to investigate whether the blood flow response to flicker stimulation is altered in patients with glaucoma.
- Conditions
- Glaucoma
- Being tested
- ocular blood flow measurements
- Keywords
- glaucoma, ficker stimulation, ocular blood flow
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ocular blood flow measurementsOther
non-invasive haemodynamic measurements of retinal vessel diameters, laser Doppler flowmetry and laser Doppler velocimetry
| Study group | Role | What they receive |
|---|---|---|
| a | 15 male and 15 female patients with glaucoma Receives: Other: ocular blood flow measurements | |
| b | 30 sex matched healthy volunteers Receives: Other: ocular blood flow measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal blood velocity (laser Doppler velocimetry)
Measured: measurements done only once on the studyday
Retinal arterial and venous diameter (Retinal vessel analyzer)
Measured: measurements done only once on the studyday
Optic nerve head blood flow (laser Doppler flowmetry)
Measured: measurements done only once on the studyday
Latency and amplitude (pattern ERG)
Measured: measurements done only once on the studyday
Secondary outcomes (1)
Mean arterial pressure
Measured: measurements done only once on the studyday
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startOct 2006
- Primary completionApr 2007
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Gabriele Fuchsjäger Mayrl, MD, Principal investigator, Department of Clinical Pharmacology, Meical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811694
- Sponsor's protocol ID
- OPHT-200104
- Status last verified
- Nov 2014
- First submitted
- 2 Jul 2008
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurovascular Coupling in Patients With Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00811694
- Acronym / sponsor ID
- OPHT-200104
- Conditions
- Glaucoma
- Keywords
- glaucoma, ficker stimulation, ocular blood flow
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 19 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.
A variety of studies demonstrate that ocular blood flow is altered in glaucoma. Various animal and human studies have shown an increase in retinal and optic nerve head blood flow in response to diffuse luminance flicker. Based on studies with ERG, this effect has been attributed to augmented activity in the retinal ganglion cells and associated axons indicating a coupling mechanism between neuronal activity and retinal blood flow. Whereas a variety of studies have confirmed these effects, the knowledge about this coupling in the retina of patients with glaucoma is sparse.
Recently the investigators could show that flicker induced vasodilatation is blunted in patients with open angle glaucoma. However, the investigators results are limited by the fact that only data about retinal vessel diameters, not blood flow per se, are available. The further development of the investigators current flicker stimulation technique now allows us to determine blood flow velocity during flicker stimulation. Thus, in the current study, the investigators set out to determine whether this blood flow response is impaired in patients with glaucoma as compared to those in healthy volunteers and whether this is related to altered neural activity.
The study objective was, to investigate whether the blood flow response to flicker stimulation is altered in patients with glaucoma.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a | – | Other: ocular blood flow measurements15 male and 15 female patients with glaucoma |
| b | – | Other: ocular blood flow measurements30 sex matched healthy volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged between 20 and 80 years.
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
- Men and women will be included in equal parts. A pregnancy test will be performed at screening.
- Ametropia of less than 3 diopters and anisometropia of less than 1 diopter.
Key exclusion criteria (6 listed)
- Treatment with vasoactive drugs.
- Presence of intraocular pathology other than open angle glaucoma.
- Presence of ocular hypertension or PEX (pseudoexfoliation) glaucoma
- History or family history of epilepsy.
- Pregnancy.
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 measurementsnon-invasive haemodynamic measurements of retinal vessel diameters, laser Doppler flowmetry and laser Doppler velocimetry | Other | a, b |
Primary outcome
Retinal blood velocity (laser Doppler velocimetry)
Time frame: measurements done only once on the studyday
Retinal arterial and venous diameter (Retinal vessel analyzer)
Time frame: measurements done only once on the studyday
Optic nerve head blood flow (laser Doppler flowmetry)
Time frame: measurements done only once on the studyday
Latency and amplitude (pattern ERG)
Time frame: measurements done only once on the studyday
1 secondary outcome
Mean arterial pressure
Time frame: measurements done only once on the studyday
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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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.
Gabriele Fuchsjäger Mayrl, MD principal investigator
Department of Clinical Pharmacology, Meical 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 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 4 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: stopped early, as of the sponsor's last update on 21 Nov 2014. 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 was stopped early. Results are not available in the source record.
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?
Retinal blood velocity (laser Doppler velocimetry) (time frame: measurements done only once on the studyday). The study lists 4 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 21 Nov 2014.