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

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT03821467
Collaborator
(none)
20
1
1
60.7
0.3

Study Details

Study Description

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
  • Device: Dual beam Doppler Fourier-domain OCT (DOCT)
  • Device: Dynamic Vessel Analyzer (DVA)
  • Device: Optical coherence tomography (OCT)
N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Nov 19, 2018
Anticipated Primary Completion Date :
Dec 12, 2023
Anticipated Study Completion Date :
Dec 12, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Retinal blood-flow variation over time [14 +/- 3 days]

    as measured using DOCT

Secondary Outcome Measures

  1. Flicker induced blood flow alterations [14 +/- 3 days]

    as measured using DOCT

  2. Flicker induced vasodilatation and hyperemia [14 +/- 3 days]

    as measured using DOCT and DVA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna, Department of Clinical Pharmacology Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Doreen Schmidl, MD, PhD, Medical University of Vienna, Department of Clinical Pharmacology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Doreen Schmidl, Associate Professor, MD, PhD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT03821467
Other Study ID Numbers:
  • OPHT-010418
First Posted:
Jan 29, 2019
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Doreen Schmidl, Associate Professor, MD, PhD, Medical University of Vienna

Study Results

No Results Posted as of Apr 7, 2022