The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain Color Doppler Optical Coherence Tomography (CDOCT)
Information source: Medical University of Vienna
Information obtained from ClinicalTrials.gov on October 31, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: 100% Oxygen (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s):
Gerhard Garhoefer, MD, Principal Investigator, Affiliation: Department of Clinical Pharmacology Medical University of Vienna
Overall contact:
Gerhard Garhoefer, MD, Phone: 0043 1 40400, Ext: 2981, Email: gerhard.garhoefer@meduniwien.ac.at
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)
Clinical Details
Official title: The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain CDOCT
Study design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Retinal blood flow (LDV, RVA)
Secondary outcome: Retinal venous diameters (Zeiss retinal vessel analyzer)Retinal blood velocity (laser Doppler velocimetry)
Eligibility
Minimum age: 19 Years.
Maximum age: 35 Years.
Gender(s): Male.
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, 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
- 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
- Ametropy equal or over 3 dpt
Locations and Contacts
Gerhard Garhoefer, MD, Phone: 0043 1 40400, Ext: 2981, Email: gerhard.garhoefer@meduniwien.ac.at
Department of Clinical Pharmacology, Vienna 1090, Austria
Additional Information
Starting date: March 2009
Ending date: March 2010
Last updated: July 16, 2008
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