NCT03821467

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
Last Updated

May 16, 2025

Status Verified

April 1, 2025

Enrollment Period

7.1 years

First QC Date

January 28, 2019

Last Update Submit

May 13, 2025

Conditions

Ocular Blood Flow

Keywords

doppler optical coherence tomographydynamic vessel analyzer

Outcome Measures

Primary Outcomes (1)

  • Retinal blood-flow variation over time

    as measured using DOCT

    14 +/- 3 days

Secondary Outcomes (2)

  • Flicker induced blood flow alterations

    14 +/- 3 days

  • Flicker induced vasodilatation and hyperemia

    14 +/- 3 days

Study Arms (1)

Healthy subjects

EXPERIMENTAL

Dual beam Doppler Fourier-domain OCT (DOCT) Dynamic Vessel Analyzer (DVA) Optical coherence tomography (OCT)

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

Interventions

Dual beam Doppler Fourier-domain OCT (DOCT)DEVICE

Retinal blood flow will be assessed using DOCT.

Healthy subjects
Dynamic Vessel Analyzer (DVA)DEVICE

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

Healthy subjects
Optical coherence tomography (OCT)DEVICE

Retinal morphology will be imaged using OCT.

Healthy subjects

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, Vienna, 1090, Austria

RECRUITING

Related Publications (3)

  • Werkmeister RM, Dragostinoff N, Palkovits S, Told R, Boltz A, Leitgeb RA, Groschl M, Garhofer G, Schmetterer L. Measurement of absolute blood flow velocity and blood flow in the human retina by dual-beam bidirectional Doppler fourier-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2012 Sep 12;53(10):6062-71. doi: 10.1167/iovs.12-9514.

    PMID: 22893675BACKGROUND

  • Doblhoff-Dier V, Schmetterer L, Vilser W, Garhofer G, Groschl M, Leitgeb RA, Werkmeister RM. Measurement of the total retinal blood flow using dual beam Fourier-domain Doppler optical coherence tomography with orthogonal detection planes. Biomed Opt Express. 2014 Jan 28;5(2):630-42. doi: 10.1364/BOE.5.000630. eCollection 2014 Feb 1.

    PMID: 24575355BACKGROUND

  • Werkmeister RM, Palkovits S, Told R, Groschl M, Leitgeb RA, Garhofer G, Schmetterer L. Response of retinal blood flow to systemic hyperoxia as measured with dual-beam bidirectional Doppler Fourier-domain optical coherence tomography. PLoS One. 2012;7(9):e45876. doi: 10.1371/journal.pone.0045876. Epub 2012 Sep 18.

    PMID: 23029289BACKGROUND

Related Links

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Doreen Schmidl, MD, PhD

    Medical University of Vienna, Department of Clinical Pharmacology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doreen Schmidl, MD, PhD

CONTACT

0043140400klin-pharmakologie@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD, PhD

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 29, 2019

Study Start

November 19, 2018

Primary Completion

December 12, 2025

Study Completion

December 12, 2025

Last Updated

May 16, 2025

Record last verified: 2025-04

Locations

AU(1)