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NCT Number: NCT03821467

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

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.

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Key information

Conditions

Ocular Blood Flow

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, State of Vienna, 1090, Austria

Location status: Recruiting

Location contact

Doreen Schmidl, MD, PhD

CONTACT

Doreen Schmidl, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual beam Doppler Fourier-domain OCT (DOCT)

Device

Retinal blood flow will be assessed using DOCT.

Dynamic Vessel Analyzer (DVA)

Device

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

Optical coherence tomography (OCT)

Device

Retinal morphology will be imaged using OCT.

Primary outcomes

  1. Retinal blood-flow variation over time

    Time frame: 14 +/- 3 days

    as measured using DOCT

Secondary outcomes

  1. Flicker induced blood flow alterations

    Time frame: 14 +/- 3 days

    as measured using DOCT

  2. Flicker induced vasodilatation and hyperemia

    Time frame: 14 +/- 3 days

    as measured using DOCT and DVA

Study contacts

Contact information is provided by the study sponsor or research team.

Doreen Schmidl, MD, PhD

CONTACT

[email protected]

0043140400 ext. 29810

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2019
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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