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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doreen Schmidl, MD, PhD; Phone Number: 29810 0043140400; Email: klin-pharmakologie@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna, Department of Clinical Pharmacology
    • Contact: Doreen Schmidl, MD, PhD
    • Principal Investigator: Doreen Schmidl, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

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)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Doreen Schmidl, MD, PhD, Medical University of Vienna, Department of Clinical Pharmacology

Publications and helpful links

General Publications

• Werkmeister RM, Dragostinoff N, Palkovits S, Told R, Boltz A, Leitgeb RA, Groschl M, Garhofer G, Schmetterer L. Measurement of absolute blood flow velocity and blood flow in the human retina by dual-beam bidirectional Doppler fourier-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2012 Sep 12;53(10):6062-71. doi: 10.1167/iovs.12-9514.
• Doblhoff-Dier V, Schmetterer L, Vilser W, Garhofer G, Groschl M, Leitgeb RA, Werkmeister RM. Measurement of the total retinal blood flow using dual beam Fourier-domain Doppler optical coherence tomography with orthogonal detection planes. Biomed Opt Express. 2014 Jan 28;5(2):630-42. doi: 10.1364/BOE.5.000630. eCollection 2014 Feb 1.
• Werkmeister RM, Palkovits S, Told R, Groschl M, Leitgeb RA, Garhofer G, Schmetterer L. Response of retinal blood flow to systemic hyperoxia as measured with dual-beam bidirectional Doppler Fourier-domain optical coherence tomography. PLoS One. 2012;7(9):e45876. doi: 10.1371/journal.pone.0045876. Epub 2012 Sep 18.

Helpful Links

• Medical University of Vienna, Department of Clinical Pharmacology

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Estimated): December 12, 2025
• Study Completion (Estimated): December 12, 2025

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: dynamic vessel analyzer; doppler optical coherence tomography
• Other Study ID Numbers: OPHT-010418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No