Clinical trial NCT03821467: Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography in Healthy Subjects
Official title: Short- and Long-term Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography Measurements in Healthy Subjects - a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ocular Blood Flow
Keywords: doppler optical coherence tomography
dynamic vessel analyzer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

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

Primary outcomes:
measure: Retinal blood-flow variation over time
timeFrame: 14 +/- 3 days
Secondary outcomes:
measure: Flicker induced blood flow alterations
timeFrame: 14 +/- 3 days
measure: Flicker induced vasodilatation and hyperemia
timeFrame: 14 +/- 3 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Clinical Pharmacology
Study officials:
affiliation: Medical University of Vienna, Department of Clinical Pharmacology
name: Doreen Schmidl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.