HealthyNCT02531399
Measurement of Total Retinal Blood Flow During Flicker Stimulation in Healthy Subjects
A study testing FDOCT, LDV and DVA in people with Healthy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Neurovascular coupling or functional hyperemia is defined as an essential physiologic mechanism in the brain, which is necessary for the local adaption of blood flow to altered metabolic demands of the tissue. It has been shown that also in the eye, blood flow is considerably coupled to retinal neural activity. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- FDOCT, LDV and DVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2015to Sep 2017
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent for participation
- Men and women aged between 18 and 45 years
- Non-smokers
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg
- Normal ophthalmic findings, ametropia less than 3 diopters
Who cannot join
- History or presence of ocular disease
- Ametropy ≥ 3 dpt
- Treatment with any drug in the 3 weeks preceding the first study day
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Participation in a clinical trial in the 3 weeks preceding the first study day
- Blood donation during the 3 weeks preceding the first study day
Show all 9Show fewer
- History of family history of epilepsy
- Abuse of alcoholic beverages
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna, Austria
Vienna, 1090
About this study
Neurovascular coupling or functional hyperemia is defined as an essential physiologic mechanism in the brain, which is necessary for the local adaption of blood flow to altered metabolic demands of the tissue. It has been shown that also in the eye, blood flow is considerably coupled to retinal neural activity. The current concept of functional hyperemia is that visual stimulation, as flicker light, effectuates increasing neural activity in the retina, which elevates the metabolic needs of the retinal tissue for oxygen and glucose and consequently induces dilatation and augmented blood flow in the retinal vasculature. In several studies, stimulation with flicker light has been shown to induce an increase of blood flow in major retinal arteries and veins as well as an increase of optic nerve head blood flow. Up until now, flicker induced changes in blood flow were measured solely in the major retinal arteries and veins with systems such as the commercially available dynamic vessel analyzer (DVA) by Imedos and with laser Doppler velocimetry (LDV).
In the present study, the investigators propose to measure the response of total retinal blood flow to diffuse luminance flicker stimulation with bi-directional Fourier Domain Doppler Optical Coherence Tomography (FDOCT) as well as with Laser Speckle Flowgraphy (LSFG) in healthy subjects by assessing vessel diameter, blood velocity and blood flow of all retinal vessels. For comparative reasons, the investigators will furthermore assess the blood flow of major retinal arteries and veins with the dynamic vessel analyzer (DVA) and laser Doppler velocimetry (LDV).
- Conditions
- Healthy
- Being tested
- FDOCT, LDV, DVA, LSFG
- Keywords
- flicker induced changes, total volumetric retinal blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDOCTDevice
Also called Fourier Domain Color Doppler Optical Coherence Tomography
Measurement of retinal blood velocities
LDVDevice
Also called Laser Doppler Velocimetry
Measurement of retinal blood velocities
DVADevice
Also called Dynamic Vessel Analyzer
Measurement of retinal vessel diameters
LSFGDevice
Also called Laser Speckle Flowgraphy
Imaging of retinal blood flow
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Experimental | 20 healthy female and male volunteers, age 18-45 years, non-smokers. Measurements with FDOCT, DVA, LDV and LSFG will be done in all healthy subjects. Receives: Device: FDOCT; Device: LDV; Device: DVA; Device: LSFG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flicker induced changes in total retinal blood flow (FDOCT)
Measured: 1 day
Secondary outcomes (4)
Red blood cell velocity (LDV)
Measured: 1 day
Retinal vessel diameters (DVA)
Measured: 1 day
Retinal oxygen saturation (DVA)
Measured: 1 day
Relative Flow Volume (LSFG)
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 posted24 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
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 Garhoefer, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531399
- Sponsor's protocol ID
- OPHT-250315
- Status last verified
- Sep 2017
- First submitted
- 20 Aug 2015
- Last updated
- 6 Sep 2017
- Results posted
- No
Publications
Fondi K, Aschinger GC, Bata AM, Wozniak PA, Liao L, Seidel G, Doblhoff-Dier V, Schmidl D, Garhofer G, Werkmeister RM, Schmetterer L. Measurement of Retinal Vascular Caliber From Optical Coherence Tomography Phase Images. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT121-9. doi: 10.1167/iovs.15-18476.
PubMed 27409462
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Total Retinal Blood Flow During Flicker Stimulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02531399
- Acronym / sponsor ID
- OPHT-250315
- Conditions
- Healthy
- Keywords
- flicker induced changes, total volumetric retinal blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 Aug 2015 (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.
Neurovascular coupling or functional hyperemia is defined as an essential physiologic mechanism in the brain, which is necessary for the local adaption of blood flow to altered metabolic demands of the tissue. It has been shown that also in the eye, blood flow is considerably coupled to retinal neural activity. The current concept of functional hyperemia is that visual stimulation, as flicker light, effectuates increasing neural activity in the retina, which elevates the metabolic needs of the retinal tissue for oxygen and glucose and consequently induces dilatation and augmented blood flow in the retinal vasculature. In several studies, stimulation with flicker light has been shown to induce an increase of blood flow in major retinal arteries and veins as well as an increase of optic nerve head blood flow. Up until now, flicker induced changes in blood flow were measured solely in the major retinal arteries and veins with systems such as the commercially available dynamic vessel analyzer (DVA) by Imedos and with laser Doppler velocimetry (LDV).
In the present study, the investigators propose to measure the response of total retinal blood flow to diffuse luminance flicker stimulation with bi-directional Fourier Domain Doppler Optical Coherence Tomography (FDOCT) as well as with Laser Speckle Flowgraphy (LSFG) in healthy subjects by assessing vessel diameter, blood velocity and blood flow of all retinal vessels. For comparative reasons, the investigators will furthermore assess the blood flow of major retinal arteries and veins with the dynamic vessel analyzer (DVA) and laser Doppler velocimetry (LDV).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Experimental | Device: FDOCT, Device: LDV, Device: DVA, Device: LSFG20 healthy female and male volunteers, age 18-45 years, non-smokers. Measurements with FDOCT, DVA, LDV and LSFG will be done in all healthy subjects. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed consent for participation
- Men and women aged between 18 and 45 years
- Non-smokers
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg
Key exclusion criteria (9 listed)
- History or presence of ocular disease
- Ametropy ≥ 3 dpt
- Treatment with any drug in the 3 weeks preceding the first study day
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Participation in a clinical trial in the 3 weeks preceding the first study day
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 |
|---|---|---|
| FDOCTAlso: Fourier Domain Color Doppler Optical Coherence TomographyMeasurement of retinal blood velocities | Device | Healthy Subjects |
| LDVAlso: Laser Doppler VelocimetryMeasurement of retinal blood velocities | Device | Healthy Subjects |
| DVAAlso: Dynamic Vessel AnalyzerMeasurement of retinal vessel diameters | Device | Healthy Subjects |
| LSFGAlso: Laser Speckle FlowgraphyImaging of retinal blood flow | Device | Healthy Subjects |
Primary outcome
Flicker induced changes in total retinal blood flow (FDOCT)
Time frame: 1 day
4 secondary outcomes
Red blood cell velocity (LDV)
Time frame: 1 day
Retinal vessel diameters (DVA)
Time frame: 1 day
Retinal oxygen saturation (DVA)
Time frame: 1 day
Relative Flow Volume (LSFG)
Time frame: 1 day
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 6 Sep 2017.
- Derived from this study: PubMed 27409462Fondi K, Aschinger GC, Bata AM, Wozniak PA, Liao L, Seidel G, Doblhoff-Dier V, Schmidl D, Garhofer G, Werkmeister RM, Schmetterer L. Measurement of Retinal Vascular Caliber From Optical Coherence Tomography Phase Images. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT121-9. doi: 10.1167/iovs.15-18476.
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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 Garhoefer, 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 FDOCT, LDV and DVA in people with Healthy, 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 6 inclusion and 9 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 6 Sep 2017. 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?
Flicker induced changes in total retinal blood flow (FDOCT) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02531399, which also lists 1 linked publication.
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 6 Sep 2017.