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Recruiting NCT03821467

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

No phase Interventional Ocular Blood Flow

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dual beam Doppler Fourier-domain OCT (DOCT), Dynamic Vessel Analyzer (DVA), Optical coherence tomography (OCT).
Who it may be relevant to
Registry conditions: Ocular Blood Flow. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Short- and Long-term Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography Measurements in Healthy Subjects - a Pilot Study

Overview

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).

Interventions

  • 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

  • Retinal blood-flow variation over time [Time frame: 14 +/- 3 days]
Secondary outcome measures (2)
  • Flicker induced blood flow alterations [Time frame: 14 +/- 3 days]
  • Flicker induced vasodilatation and hyperemia [Time frame: 14 +/- 3 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Austria · 1 center
  • Medical University of Vienna, Department of Clinical Pharmacology — Vienna

Publications

  • 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 22893675
  • 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 24575355
  • 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 23029289

Identifiers

NCT: NCT03821467 · OPHT-010418

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗