- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1090
- Department of Clinical Pharmacology, Medical University of Vienna, Austria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy Subjects
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.
|
Measurement of retinal blood velocities
Other Names:
Measurement of retinal blood velocities
Other Names:
Measurement of retinal vessel diameters
Other Names:
Imaging of retinal blood flow
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Flicker induced changes in total retinal blood flow (FDOCT)
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Red blood cell velocity (LDV)
Time Frame: 1 day
|
1 day
|
|
Retinal vessel diameters (DVA)
Time Frame: 1 day
|
1 day
|
|
Retinal oxygen saturation (DVA)
Time Frame: 1 day
|
1 day
|
|
Relative Flow Volume (LSFG)
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OPHT-250315
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.