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Completed

NCT Number: NCT02531399

Measurement of Total Retinal Blood Flow During Flicker Stimulation in Healthy Subjects

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).

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology, Medical University of Vienna, Austria

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • History of family history of epilepsy
  • Abuse of alcoholic beverages
  • Pregnancy

Treatment and study plan

FDOCT

Device

Measurement of retinal blood velocities

Other names: Fourier Domain Color Doppler Optical Coherence Tomography

LDV

Device

Measurement of retinal blood velocities

Other names: Laser Doppler Velocimetry

DVA

Device

Measurement of retinal vessel diameters

Other names: Dynamic Vessel Analyzer

LSFG

Device

Imaging of retinal blood flow

Other names: Laser Speckle Flowgraphy

Primary outcomes

  1. Flicker induced changes in total retinal blood flow (FDOCT)

    Time frame: 1 day

Secondary outcomes

  1. Red blood cell velocity (LDV)

    Time frame: 1 day

  2. Retinal vessel diameters (DVA)

    Time frame: 1 day

  3. Retinal oxygen saturation (DVA)

    Time frame: 1 day

  4. Relative Flow Volume (LSFG)

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 24, 2015
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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