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Clinical Trials/NCT03821467
NCT03821467RecruitingNot Applicable

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

Medical University of Vienna2 sites in 1 country20 target enrollmentStarted: November 19, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
2
Primary Endpoint
Retinal blood-flow variation over time

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Retinal blood-flow variation over time

Time Frame: 14 +/- 3 days

as measured using DOCT

Secondary Outcomes

  • Flicker induced blood flow alterations(14 +/- 3 days)
  • Flicker induced vasodilatation and hyperemia(14 +/- 3 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Doreen Schmidl

Associate Professor, MD, PhD

Medical University of Vienna

Study Sites (2)

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