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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: FDOCT; Device: LDV; Device: DVA; Device: LSFG

• Registration Number: NCT02531399
• Lead Sponsor: Medical University of Vienna

Brief 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. 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-21
• Study First Posted: 2015-08-24
• Study Start: 2015-10
• Primary Completion: 2017-08
• Status Verified: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-02
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Subjects	DVA	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.
Healthy Subjects	LDV	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.
Healthy Subjects	LSFG	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.
Healthy Subjects	FDOCT	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.

Primary Outcome Measures

Name	Time	Method
Flicker induced changes in total retinal blood flow (FDOCT)	1 day

Secondary Outcome Measures

Name	Time	Method
Retinal vessel diameters (DVA)	1 day
Relative Flow Volume (LSFG)	1 day
Red blood cell velocity (LDV)	1 day
Retinal oxygen saturation (DVA)	1 day

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna, Austria; 🇦🇹 Vienna, Austria