Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography in Healthy Subjects

Study Overview
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Brief Summary
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Dual beam Doppler Fourier-domain Optical coherence tomography (DOCT) is a noninvasive technique to quantify total retinal blood flow. To enable further development of this technique it is essential to assess short- and long-term reproducibility of DOCT blood flow measurements.

Detailed Description
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In the present study, total retinal blood flow will be measured with DOCT at multiple time points to gain information of short- and long-term reproducibility. In addition, provocation with flickering light will be performed, which is known to lead to vasodilatation and an increase in retinal blood flow in healthy subjects. Vessel diameters will also be measured using the Dynamic Vessel Analyzer (DVA).

Official Title
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Short- and Long-term Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography Measurements in Healthy Subjects - a Pilot Study

Conditions
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Ocular Blood Flow

Intervention / Treatment
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* Device: Dual beam Doppler Fourier-domain OCT (DOCT)
* Device: Dynamic Vessel Analyzer (DVA)
* Device: Optical coherence tomography (OCT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged between 18 and 35 years Non-smokers Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant Normal ophthalmic findings, ametropy < 3 Dpt. Exclusion Criteria: Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study Treatment in the previous 3 weeks with any drug (except contraceptives) Symptoms of a clinically relevant illness in the 3 weeks before the first study day Blood donation during the previous 3 weeks Pregnancy, planned pregnancy or lactating History or family history of epilepsia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subjects<br>Dual beam Doppler Fourier-domain OCT (DOCT) Dynamic Vessel Analyzer (DVA) Optical coherence tomography (OCT) | Device: Dual beam Doppler Fourier-domain OCT (DOCT)<br>* Retinal blood flow will be assessed using DOCT.<br>Device: Dynamic Vessel Analyzer (DVA)<br>* Retinal vessel diameters and oxygen saturation will be measured with the DVA device.<br>Device: Optical coherence tomography (OCT)<br>* Retinal morphology will be imaged using OCT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal blood-flow variation over time | as measured using DOCT | 14 +/- 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flicker induced blood flow alterations | as measured using DOCT | 14 +/- 3 days | 
| Flicker induced vasodilatation and hyperemia | as measured using DOCT and DVA | 14 +/- 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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doppler optical coherence tomography, dynamic vessel analyzer