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

Not Applicable

• Conditions: Ocular Blood Flow
• Interventions: Device: Dual beam Doppler Fourier-domain OCT (DOCT); Device: Dynamic Vessel Analyzer (DVA); Device: Optical coherence tomography (OCT)

• Registration Number: NCT03821467
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

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).

Study Timeline

• Study Start: 2018-11-19
• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07
• Primary Completion: 2023-12-12
• Study Completion: 2023-12-12

Recruitment & Eligibility

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

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Dual beam Doppler Fourier-domain OCT (DOCT)	Dual beam Doppler Fourier-domain OCT (DOCT) Dynamic Vessel Analyzer (DVA) Optical coherence tomography (OCT)
Healthy subjects	Optical coherence tomography (OCT)	Dual beam Doppler Fourier-domain OCT (DOCT) Dynamic Vessel Analyzer (DVA) Optical coherence tomography (OCT)
Healthy subjects	Dynamic Vessel Analyzer (DVA)	Dual beam Doppler Fourier-domain OCT (DOCT) Dynamic Vessel Analyzer (DVA) Optical coherence tomography (OCT)

Primary Outcome Measures

Name	Time	Method
Retinal blood-flow variation over time	14 +/- 3 days	as measured using DOCT

Secondary Outcome Measures

Name	Time	Method
Flicker induced blood flow alterations	14 +/- 3 days	as measured using DOCT
Flicker induced vasodilatation and hyperemia	14 +/- 3 days	as measured using DOCT and DVA

Trial Locations

Locations (1)

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