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RecruitingNCT03821467Updated May 16, 2025

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

An interventional study of Dual beam Doppler Fourier-domain OCT (DOCT) and Dynamic Vessel Analyzer (DVA) in Ocular Blood Flow, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Nov 2018; still recruiting 7 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Ocular Blood Flow

Keywords

  • doppler optical coherence tomography
  • dynamic vessel analyzer
03

In context

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Healthy subjects

    Dual beam Doppler Fourier-domain OCT (DOCT) Dynamic Vessel Analyzer (DVA) Optical coherence tomography (OCT)

    Device: Dual beam Doppler Fourier-domain OCT (DOCT) · Device: Dynamic Vessel Analyzer (DVA) · Device: Optical coherence tomography (OCT)

Interventions

  • DeviceDual beam Doppler Fourier-domain OCT (DOCT)

    Retinal blood flow will be assessed using DOCT.

  • DeviceDynamic Vessel Analyzer (DVA)

    Retinal vessel diameters and oxygen saturation will be measured with the DVA device.

  • DeviceOptical coherence tomography (OCT)

    Retinal morphology will be imaged using OCT.

06

What researchers measure

Primary outcomes

  1. Retinal blood-flow variation over time

    as measured using DOCT

    Time frame: 14 +/- 3 days

Secondary outcomes

  1. Flicker induced blood flow alterations

    as measured using DOCT

    Time frame: 14 +/- 3 days

  2. Flicker induced vasodilatation and hyperemia

    as measured using DOCT and DVA

    Time frame: 14 +/- 3 days

07

Study locations

1 of 1 sites recruiting
  • Medical University of Vienna, Department of Clinical Pharmacology
    Vienna, 1090, Austria
    • Doreen Schmidl, MD, PhD · Contact
    • Doreen Schmidl, MD, PhD · Principal investigator
    Recruiting
08

References and documents

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. PubMed 22893675 ↗
  • 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. PubMed 24575355 ↗
  • 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. PubMed 23029289 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03821467
Lead sponsor
Medical University of Vienna
Responsible party
Doreen Schmidl (Associate Professor, MD, PhD, Medical University of Vienna) — Principal investigator
First posted
Jan 29, 2019
Start date
Nov 19, 2018
Primary completion
Dec 12, 2025 (estimated)
Completion
Dec 12, 2025 (estimated)
Last update
May 16, 2025

Study contacts

Doreen Schmidl, MD, PhD
Contact
klin-pharmakologie@meduniwien.ac.at
0043140400 ext. 29810
Doreen Schmidl, MD, PhD
principal investigator · Medical University of Vienna, Department of Clinical Pharmacology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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