Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography in Healthy Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03821467|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : February 20, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Ocular Blood Flow||Device: Dual beam Doppler Fourier-domain OCT (DOCT) Device: Dynamic Vessel Analyzer (DVA) Device: Optical coherence tomography (OCT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Short- and Long-term Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography Measurements in Healthy Subjects - a Pilot Study|
|Actual Study Start Date :||November 19, 2018|
|Estimated Primary Completion Date :||December 12, 2020|
|Estimated Study Completion Date :||December 12, 2020|
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)
Retinal blood flow will be assessed using DOCT.
Device: Dynamic Vessel Analyzer (DVA)
Retinal vessel diameters and oxygen saturation will be measured with the DVA device.
Device: Optical coherence tomography (OCT)
Retinal morphology will be imaged using OCT.
- Retinal blood-flow variation over time [ Time Frame: 14 +/- 3 days ]as measured using DOCT
- Flicker induced blood flow alterations [ Time Frame: 14 +/- 3 days ]as measured using DOCT
- Flicker induced vasodilatation and hyperemia [ Time Frame: 14 +/- 3 days ]as measured using DOCT and DVA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821467
|Contact: Doreen Schmidl, MD, PhD||0043140400 ext firstname.lastname@example.org|
|Medical University of Vienna, Department of Clinical Pharmacology||Recruiting|
|Vienna, Austria, 1090|
|Contact: Doreen Schmidl, MD, PhD|
|Principal Investigator: Doreen Schmidl, MD, PhD|
|Principal Investigator:||Doreen Schmidl, MD, PhD||Medical University of Vienna, Department of Clinical Pharmacology|