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

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ClinicalTrials.gov Identifier: NCT03821467
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Doreen Schmidl, 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.


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

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
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, 2021
Estimated Study Completion Date : December 12, 2021

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Retinal blood-flow variation over time [ Time Frame: 14 +/- 3 days ]
    as measured using DOCT


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Doreen Schmidl, MD, PhD 0043140400 ext 29810 klin-pharmakologie@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna, Department of Clinical Pharmacology Recruiting
Vienna, Austria, 1090
Contact: Doreen Schmidl, MD, PhD         
Principal Investigator: Doreen Schmidl, MD, PhD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Doreen Schmidl, MD, PhD Medical University of Vienna, Department of Clinical Pharmacology
Additional Information:
Publications:
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Responsible Party: Doreen Schmidl, Associate Professor, MD, PhD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03821467    
Other Study ID Numbers: OPHT-010418
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Doreen Schmidl, Medical University of Vienna:
doppler optical coherence tomography
dynamic vessel analyzer