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

Ocular Blood Flow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821467
• Other study ID #: OPHT-010418
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: December 12, 2023

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: Doreen Schmidl, MD, PhD
• Phone: 0043140400
• Email: klin-pharmakologie[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Ocular Blood Flow

Intervention

Device:
• Dual beam Doppler Fourier-domain OCT (DOCT)
Retinal blood flow will be assessed using DOCT.
• Dynamic Vessel Analyzer (DVA)
Retinal vessel diameters and oxygen saturation will be measured with the DVA device.
• Optical coherence tomography (OCT)
Retinal morphology will be imaged using OCT.

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (3)

Doblhoff-Dier V, Schmetterer L, Vilser W, Garhöfer G, Gröschl 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. — View Citation

Werkmeister RM, Dragostinoff N, Palkovits S, Told R, Boltz A, Leitgeb RA, Gröschl M, Garhöfer 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. — View Citation

Werkmeister RM, Palkovits S, Told R, Gröschl M, Leitgeb RA, Garhöfer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal blood-flow variation over time	as measured using DOCT	14 +/- 3 days
Secondary	Flicker induced blood flow alterations	as measured using DOCT	14 +/- 3 days
Secondary	Flicker induced vasodilatation and hyperemia	as measured using DOCT and DVA	14 +/- 3 days

External Links

•   Medical University of Vienna, Department of Clinical Pharmacology