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

NCT ID: NCT03821467

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2025-12-12

Brief Summary

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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

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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).

Conditions

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Ocular Blood Flow

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy subjects

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

Group Type EXPERIMENTAL

Dual beam Doppler Fourier-domain OCT (DOCT)

Intervention Type DEVICE

Retinal blood flow will be assessed using DOCT.

Dynamic Vessel Analyzer (DVA)

Intervention Type DEVICE

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

Optical coherence tomography (OCT)

Intervention Type DEVICE

Retinal morphology will be imaged using OCT.

Interventions

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Dual beam Doppler Fourier-domain OCT (DOCT)

Retinal blood flow will be assessed using DOCT.

Intervention Type DEVICE

Dynamic Vessel Analyzer (DVA)

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

Intervention Type DEVICE

Optical coherence tomography (OCT)

Retinal morphology will be imaged using OCT.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Doreen Schmidl

Associate Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doreen Schmidl, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Clinical Pharmacology

Locations

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Medical University of Vienna, Department of Clinical Pharmacology

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Doreen Schmidl, MD, PhD

Role: CONTACT

0043140400 ext. 29810

Facility Contacts

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Doreen Schmidl, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22893675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24575355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23029289 (View on PubMed)

Related Links

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https://klpharm.meduniwien.ac.at/

Medical University of Vienna, Department of Clinical Pharmacology

Other Identifiers

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OPHT-010418

Identifier Type: -

Identifier Source: org_study_id

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