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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

Tracking Information
First Submitted Date  ICMJE January 28, 2019
First Posted Date  ICMJE January 29, 2019
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE November 19, 2018
Estimated Primary Completion Date December 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
Retinal blood-flow variation over time [ Time Frame: 14 +/- 3 days ]
as measured using DOCT
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography in Healthy Subjects
Official Title  ICMJE Short- and Long-term Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography Measurements in Healthy Subjects - a Pilot Study
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Ocular Blood Flow
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Healthy subjects
Dual beam Doppler Fourier-domain OCT (DOCT) Dynamic Vessel Analyzer (DVA) Optical coherence tomography (OCT)
Interventions:
  • Device: Dual beam Doppler Fourier-domain OCT (DOCT)
  • Device: Dynamic Vessel Analyzer (DVA)
  • Device: Optical coherence tomography (OCT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 12, 2021
Estimated Primary Completion Date December 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Doreen Schmidl, MD, PhD 0043140400 ext 29810 klin-pharmakologie@meduniwien.ac.at
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03821467
Other Study ID Numbers  ICMJE OPHT-010418
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Doreen Schmidl, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Doreen Schmidl, MD, PhD Medical University of Vienna, Department of Clinical Pharmacology
PRS Account Medical University of Vienna
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP