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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
  • Department of Clinical Pharmacology, Medical University of Vienna

    Vienna

    Gerhard Garhöfer, MD

    Recruiting

Other trials in Austria

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 groups in NCT03870230
Study groupRoleWhat they receive
POAG MD<10dBExperimentalpatients 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>10dBExperimentalpatients 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<10dBExperimentalpatients 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>10dBExperimentalpatients 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)
OHTExperimentalpatients 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)
controlsExperimentalhealthy, 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.

  1. 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.

  1. First posted12 Mar 2019
  2. Study start1 Dec 2017
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

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)
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

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.

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