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The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain Color Doppler Optical Coherence Tomography (CDOCT)

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
100% Oxygen
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy focused on measuring Regional Blood Flow, Color Doppler Optical Coherence Tomography, CDOCT, Retinal Blood Flow, Hyperoxia, Vasoconstriction, Laser Doppler Velocimetry, Retinal Vessel Analyzer

Eligibility Criteria

19 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Men aged between 19 and 35 years, nonsmokers
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropia < 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
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
  • Blood donation during the previous 3 weeks
  • Ametropia equal or over 3 dpt

Sites / Locations

  • Department of Clinical Pharmacology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

12 healthy male subjects

Outcomes

Primary Outcome Measures

Retinal blood flow (LDV, RVA)

Secondary Outcome Measures

Retinal venous diameters (Zeiss retinal vessel analyzer)
Retinal blood velocity (laser Doppler velocimetry)

Full Information

First Posted
February 5, 2007
Last Updated
June 7, 2018
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00431600
Brief Title
The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain Color Doppler Optical Coherence Tomography (CDOCT)
Official Title
The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain CDOCT
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Noninvasive monitoring of blood flow in retinal circulation may elucidate the progression and treatment of ocular disorders, including diabetic retinopathy, age-related macular degeneration and glaucoma. Laser Doppler velocimetry (LDV), a noninvasive optical method combined with vessel size determination has been used extensively as a valuable research tool to examine blood flow dynamics in the human retina. However, no information on the velocity profile within the vessel is available. Ophthalmic color Doppler optical coherence tomography (CDOCT) provides laser Doppler information in addition to conventional optical coherence tomography, allowing the observation of blood flow dynamics simultaneously to imaging retinal structure. We have recently demonstrated the feasibility of Fourier domain CDOCT to assess velocity profiles in human retinal vessels in vivo. In the present study the validity of Fourier domain CDOCT for retinal blood flow measurements will be tested at baseline and during hyperoxia-induced vasoconstriction in humans by comparison with retinal blood flow measurements using a commercially available LDV system and the Zeiss retinal vessel analyzer (RVA)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Regional Blood Flow, Color Doppler Optical Coherence Tomography, CDOCT, Retinal Blood Flow, Hyperoxia, Vasoconstriction, Laser Doppler Velocimetry, Retinal Vessel Analyzer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
12 healthy male subjects
Intervention Type
Other
Intervention Name(s)
100% Oxygen
Intervention Description
100% Oxygen- breathing over 30 minutes
Primary Outcome Measure Information:
Title
Retinal blood flow (LDV, RVA)
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Retinal venous diameters (Zeiss retinal vessel analyzer)
Time Frame
5 minutes
Title
Retinal blood velocity (laser Doppler velocimetry)
Time Frame
10 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men aged between 19 and 35 years, nonsmokers Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Normal ophthalmic findings, ametropia < 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 Symptoms of a clinically relevant illness in the 3 weeks before the first study day History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs Blood donation during the previous 3 weeks Ametropia equal or over 3 dpt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhoefer, MD
Organizational Affiliation
Department of Clinical Pharmacology Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain Color Doppler Optical Coherence Tomography (CDOCT)

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