- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00431600
The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain Color Doppler Optical Coherence Tomography (CDOCT)
The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain CDOCT
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)
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1090
- Department of Clinical Pharmacology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
12 healthy male subjects
|
100% Oxygen- breathing over 30 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Retinal blood flow (LDV, RVA)
Time Frame: 15 minutes
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Retinal venous diameters (Zeiss retinal vessel analyzer)
Time Frame: 5 minutes
|
5 minutes
|
Retinal blood velocity (laser Doppler velocimetry)
Time Frame: 10 minutes
|
10 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerhard Garhoefer, MD, Department of Clinical Pharmacology Medical University of Vienna
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPHT-121103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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