Glaucoma, Open-AngleNCT03870230
Investigation of Neurovascular Coupling in Glaucoma Patients and Healthy Subjects
A study testing Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Dynamic Vessel Analyzer (DVA) and Pattern Electroretinography (pERG) in people with Glaucoma, Open-Angle and Normal Tension Glaucoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Glaucoma is characterized by a progressive loss of retinal ganglion cells (RGCs) leading to optic nerve head (ONH) damage and associated visual field defects. The main risk factor for glaucoma is elevated intraocular pressure (IOP). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle, Normal Tension Glaucoma, Ocular Hypertension
- What is being tested?
- Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Dynamic Vessel Analyzer (DVA) and Pattern Electroretinography (pERG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2017to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with primary open angle glaucoma
- Diagnosis of manifest primary open angle glaucoma defined as pathological optic disc appearance
- Glaucoma hemifield test outside normal limits
- Untreated IOP ≥ 21 mmHg on at least three measurements in the medical history
- Mean deviation in the visual field test is less than or equal 10dB (for one group) OR more than 10dB (for the other group)
- Patients with normal tension glaucoma
Show all 20Show fewer
- Diagnosis of manifest normal tension glaucoma defined as pathological optic disc appearance
- Glaucoma hemifield test outside normal limits
- No evidence of untreated IOP > 20 mmHg in the medical history
- Mean deviation in the visual field is less than or equal 10dB (for one group) OR more than 10dB (for the other group)
- Patients with ocular hypertension
- Normal ophthalmic findings except presence of ocular hypertension defined as untreated IOP ≥ 21 mmHg on at least three measurements in the medical history
- No signs of glaucomatous damage in the optic disc
- or the glaucoma hemifield test
- Healthy control subjects
- Normal ophthalmic findings
- IOP < 20 mmHg on least three measurements
- No evidence of increased IOP in the medical history
- No signs of glaucomatous damage in the optic disc
- or the glaucoma hemifield test
Who cannot join
- History of a severe medical condition as judged by the clinical investigator
- Abuse of alcoholic beverages
- Smoker
- Participation in a clinical trial in the 3 weeks preceding the study
- Exfoliation glaucoma, pigmentary glaucoma, history of acute angle closure
- Intraocular surgery within the last 6 months
Show all 12Show fewer
- Ocular inflammation or infection within the last 3 months
- History of epilepsia
- Diabetes mellitus
- Untreated hypertension with systolic blood pressure > 160 mmHg, diastolic blood pressure > 95 mmHg
- Pregnancy
- Planned pregnancy or lactating
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Clinical Pharmacology, Medical University of Vienna
Vienna
Gerhard Garhöfer, MD
About this study
Glaucoma is characterized by a progressive loss of retinal ganglion cells (RGCs) leading to optic nerve head (ONH) damage and associated visual field defects. The main risk factor for glaucoma is elevated intraocular pressure (IOP). Reducing IOP slows down the progression of the disease as several large multicenter trials have shown. Some patients, however, still progress despite adequately controlled IOP. As such, there is considerable interest in approaches that rescue RGCs independent of IOP, a strategy called neuroprotection. Although this field was actively discovered in the last 20 years in the brain and the eye, no non-IOP related treatment is clinically available to date. Various approaches are currently studied in some detail. One interesting strategy focuses on the neurovascular unit.
The blood flow of the human retina is controlled by complex mechanisms that include myogenic, metabolic and hormonal factors. The high consumption of oxygen in the human retina is crucial for normal functioning of the organ. As in the brain, blood flow in the retina is also controlled by neurovascular coupling. This means that the retina increases its blood flow to regions in which neurons are activated. This is done in an effort to provide more oxygen and glucose to the active neurons. In the recent years evidence has accumulated that astrocytes play a key role in mediating this vasodilator signal.
Read more
In the brain, abnormalities in neurovascular coupling have been observed in diseases like stroke, hypertension, spinal-cord injury and Alzheimer's disease. This break-down of neurovascular coupling is considered to play a key role in neuronal death in these diseases. In the retina, abnormalities in neurovascular coupling have been observed in diseases as diabetes and glaucoma.
Most of the data obtained in the human retina stem from a system that measures retinal vasodilatation during stimulation with flickering light. The investigators have previously shown that flicker stimulation of the retina is, however, also associated with a pronounced increase in retinal blood velocities. In this study the investigators employed laser Doppler velocimetry (LDV) for the measurement of retinal blood velocities, but this technique is not clinically applicable because it requires excellent fixation of the subject under study. In the present study, the investigators propose to use an alternative system for neurovascular coupling that they have developed recently. In this approach, the investigators use bi-directional Fourier-domain optical coherence tomography for the assessment of retinal blood flow. Optical coherence tomography (OCT) is a non-invasive optical imaging modality enabling cross-sectional tomographic in vivo visualization of internal microstructure in biological systems. In ophthalmology, OCT has become a standard tool in visualizing the retina and nowadays is considered also as a standard tool in the diagnosis of retinal disease. In the recent years, conventional time domain OCT was replaced by Fourier domain OCT providing significantly improved signal quality.
This bidirectional system overcomes the limitations of previously realized techniques, which include doubtful validity and limited reproducibility. In addition, pattern ERG, multifocal ERG and oscillatory potentials will be measured to allow for concomitant assessment of neural function.
The investigators seek to measure neurovascular coupling in the human retina in patients with early primary open angle glaucoma (POAG), normal tension glaucoma, ocular hypertension and a healthy control group. In order to obtain information on neurovascular coupling, both neuronal function as well as retinal blood flow need to be measured. In the present study, the investigators will employ pattern ERG, multifocal ERG as well as oscillatory potentials to assess the function of the inner retina. Retinal blood flow through major retinal arterial and venous branch vessels will be measured before, during and after flicker stimulation with the dual-beam bidirectional Fourier Domain Doppler OCT coupled to the commercially available Dynamic Vessel Analyzer (DVA) produced by IMEDOS, Jena, Germany, which provides adequate resolution to study the retinal circulation.
- Being tested
- Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Dynamic Vessel Analyzer (DVA), Pattern Electroretinography (pERG), Optical coherence tomography (OCT), Laser Speckle Flowgraphy (LSFG)
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fourier Domain Doppler Optical Coherence Tomography (FDOCT)Device
Retinal blood flow will be assessed using FDOCT
Dynamic Vessel Analyzer (DVA)Device
Retinal vessel diameters and oxygen saturation will be measured with the DVA device
Pattern Electroretinography (pERG)Device
to assess the neuronal function of the retina, pattern ERG will be performed
Optical coherence tomography (OCT)Device
to assess the morphology of the retina, OCT will be performed
Laser Speckle Flowgraphy (LSFG)Device
to assess retinal blood flow, LSFG will be performed
| Study group | Role | What they receive |
|---|---|---|
| POAG MD<10dB | Experimental | patients with primary open angle glaucoma with MD in visual field less than or equal 10dB Receives: Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Device: Dynamic Vessel Analyzer (DVA); Device: Pattern Electroretinography (pERG); Device: Optical coherence tomography (OCT); Device: Laser Speckle Flowgraphy (LSFG) |
| POAG MD>10dB | Experimental | patients with primary open angle glaucoma with MD in visual field more than 10dB Receives: Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Device: Dynamic Vessel Analyzer (DVA); Device: Pattern Electroretinography (pERG); Device: Optical coherence tomography (OCT); Device: Laser Speckle Flowgraphy (LSFG) |
| NTG MD<10dB | Experimental | patients with normal tension glaucoma with MD in visual field less than or equal 10dB Receives: Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Device: Dynamic Vessel Analyzer (DVA); Device: Pattern Electroretinography (pERG); Device: Optical coherence tomography (OCT); Device: Laser Speckle Flowgraphy (LSFG) |
| NTG MD>10dB | Experimental | patients with normal tension glaucoma with MD in visual field more than 10dB Receives: Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Device: Dynamic Vessel Analyzer (DVA); Device: Pattern Electroretinography (pERG); Device: Optical coherence tomography (OCT); Device: Laser Speckle Flowgraphy (LSFG) |
| OHT | Experimental | patients with ocular hypertension Receives: Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Device: Dynamic Vessel Analyzer (DVA); Device: Pattern Electroretinography (pERG); Device: Optical coherence tomography (OCT); Device: Laser Speckle Flowgraphy (LSFG) |
| controls | Experimental | healthy, age and sex matched, control subjects Receives: Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Device: Dynamic Vessel Analyzer (DVA); Device: Pattern Electroretinography (pERG); Device: Optical coherence tomography (OCT); Device: Laser Speckle Flowgraphy (LSFG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flicker induced blood flow alterations
Response of retinal blood flow to flicker light
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Dec 2017
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
- Investigators
- Gerhard Garhöfer, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870230
- Sponsor's protocol ID
- OPHT-010213
- Status last verified
- Apr 2025
- First submitted
- 8 Mar 2019
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Neurovascular Coupling in Glaucoma Patients and Healthy Subjects
- ClinicalTrials.gov ID
- NCT03870230
- Acronym / sponsor ID
- OPHT-010213
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 12 Mar 2019 (actual)
- 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 characterized by a progressive loss of retinal ganglion cells (RGCs) leading to optic nerve head (ONH) damage and associated visual field defects. The main risk factor for glaucoma is elevated intraocular pressure (IOP). Reducing IOP slows down the progression of the disease as several large multicenter trials have shown. Some patients, however, still progress despite adequately controlled IOP. As such, there is considerable interest in approaches that rescue RGCs independent of IOP, a strategy called neuroprotection. Although this field was actively discovered in the last 20 years in the brain and the eye, no non-IOP related treatment is clinically available to date. Various approaches are currently studied in some detail. One interesting strategy focuses on the neurovascular unit.
The blood flow of the human retina is controlled by complex mechanisms that include myogenic, metabolic and hormonal factors. The high consumption of oxygen in the human retina is crucial for normal functioning of the organ. As in the brain, blood flow in the retina is also controlled by neurovascular coupling. This means that the retina increases its blood flow to regions in which neurons are activated. This is done in an effort to provide more oxygen and glucose to the active neurons. In the recent years evidence has accumulated that astrocytes play a key role in mediating this vasodilator signal.
In the brain, abnormalities in neurovascular coupling have been observed in diseases like stroke, hypertension, spinal-cord injury and Alzheimer's disease. This break-down of neurovascular coupling is considered to play a key role in neuronal death in these diseases. In the retina, abnormalities in neurovascular coupling have been observed in diseases as diabetes and glaucoma.
Most of the data obtained in the human retina stem from a system that measures retinal vasodilatation during stimulation with flickering light. The investigators have previously shown that flicker stimulation of the retina is, however, also associated with a pronounced increase in retinal blood velocities. In this study the investigators employed laser Doppler velocimetry (LDV) for the measurement of retinal blood velocities, but this technique is not clinically applicable because it requires excellent fixation of the subject under study. In the present study, the investigators propose to use an alternative system for neurovascular coupling that they have developed recently. In this approach, the investigators use bi-directional Fourier-domain optical coherence tomography for the assessment of retinal blood flow. Optical coherence tomography (OCT) is a non-invasive optical imaging modality enabling cross-sectional tomographic in vivo visualization of internal microstructure in biological systems. In ophthalmology, OCT has become a standard tool in visualizing the retina and nowadays is considered also as a standard tool in the diagnosis of retinal disease. In the recent years, conventional time domain OCT was replaced by Fourier domain OCT providing significantly improved signal quality.
This bidirectional system overcomes the limitations of previously realized techniques, which include doubtful validity and limited reproducibility. In addition, pattern ERG, multifocal ERG and oscillatory potentials will be measured to allow for concomitant assessment of neural function.
The investigators seek to measure neurovascular coupling in the human retina in patients with early primary open angle glaucoma (POAG), normal tension glaucoma, ocular hypertension and a healthy control group. In order to obtain information on neurovascular coupling, both neuronal function as well as retinal blood flow need to be measured. In the present study, the investigators will employ pattern ERG, multifocal ERG as well as oscillatory potentials to assess the function of the inner retina. Retinal blood flow through major retinal arterial and venous branch vessels will be measured before, during and after flicker stimulation with the dual-beam bidirectional Fourier Domain Doppler OCT coupled to the commercially available Dynamic Vessel Analyzer (DVA) produced by IMEDOS, Jena, Germany, which provides adequate resolution to study the retinal circulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| POAG MD<10dB | Experimental | Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Device: Dynamic Vessel Analyzer (DVA), Device: Pattern Electroretinography (pERG), Device: Optical coherence tomography (OCT), Device: Laser Speckle Flowgraphy (LSFG)patients with primary open angle glaucoma with MD in visual field less than or equal 10dB |
| POAG MD>10dB | Experimental | Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Device: Dynamic Vessel Analyzer (DVA), Device: Pattern Electroretinography (pERG), Device: Optical coherence tomography (OCT), Device: Laser Speckle Flowgraphy (LSFG)patients with primary open angle glaucoma with MD in visual field more than 10dB |
| NTG MD<10dB | Experimental | Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Device: Dynamic Vessel Analyzer (DVA), Device: Pattern Electroretinography (pERG), Device: Optical coherence tomography (OCT), Device: Laser Speckle Flowgraphy (LSFG)patients with normal tension glaucoma with MD in visual field less than or equal 10dB |
| NTG MD>10dB | Experimental | Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Device: Dynamic Vessel Analyzer (DVA), Device: Pattern Electroretinography (pERG), Device: Optical coherence tomography (OCT), Device: Laser Speckle Flowgraphy (LSFG)patients with normal tension glaucoma with MD in visual field more than 10dB |
| OHT | Experimental | Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Device: Dynamic Vessel Analyzer (DVA), Device: Pattern Electroretinography (pERG), Device: Optical coherence tomography (OCT), Device: Laser Speckle Flowgraphy (LSFG)patients with ocular hypertension |
| controls | Experimental | Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Device: Dynamic Vessel Analyzer (DVA), Device: Pattern Electroretinography (pERG), Device: Optical coherence tomography (OCT), Device: Laser Speckle Flowgraphy (LSFG)healthy, age and sex matched, control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients with primary open angle glaucoma
- Diagnosis of manifest primary open angle glaucoma defined as pathological optic disc appearance
- Glaucoma hemifield test outside normal limits
- Untreated IOP ≥ 21 mmHg on at least three measurements in the medical history
- Mean deviation in the visual field test is less than or equal 10dB (for one group) OR more than 10dB (for the other group)
Key exclusion criteria (12 listed)
- History of a severe medical condition as judged by the clinical investigator
- Abuse of alcoholic beverages
- Smoker
- Participation in a clinical trial in the 3 weeks preceding the study
- Exfoliation glaucoma, pigmentary glaucoma, history of acute angle closure
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 |
|---|---|---|
| Fourier Domain Doppler Optical Coherence Tomography (FDOCT)Retinal blood flow will be assessed using FDOCT | Device | NTG MD<10dB, NTG MD>10dB, OHT, POAG MD<10dB, POAG MD>10dB, controls |
| Dynamic Vessel Analyzer (DVA)Retinal vessel diameters and oxygen saturation will be measured with the DVA device | Device | NTG MD<10dB, NTG MD>10dB, OHT, POAG MD<10dB, POAG MD>10dB, controls |
| Pattern Electroretinography (pERG)to assess the neuronal function of the retina, pattern ERG will be performed | Device | NTG MD<10dB, NTG MD>10dB, OHT, POAG MD<10dB, POAG MD>10dB, controls |
| Optical coherence tomography (OCT)to assess the morphology of the retina, OCT will be performed | Device | NTG MD<10dB, NTG MD>10dB, OHT, POAG MD<10dB, POAG MD>10dB, controls |
| Laser Speckle Flowgraphy (LSFG)to assess retinal blood flow, LSFG will be performed | Device | NTG MD<10dB, NTG MD>10dB, OHT, POAG MD<10dB, POAG MD>10dB, controls |
Primary outcome
Flicker induced blood flow alterations
Time frame: 1 day
Response of retinal blood flow to flicker light
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Dynamic Vessel Analyzer (DVA) and Pattern Electroretinography (pERG) in people with Glaucoma, Open-Angle and Normal Tension 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 20 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 23 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Garhöfer, MD (004314040029810, gerhard.garhoefer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flicker induced blood flow alterations (time frame: 1 day). 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 23 May 2025.