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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2008 by Medical University of Vienna. Recruitment status was Not yet recruiting

First Received on February 5, 2007. Last Updated on July 30, 2010 History of Changes

Sponsor:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00431600

Purpose

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)

Condition	Intervention
Healthy	Other: 100% Oxygen

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain CDOCT

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Retinal blood flow (LDV, RVA) [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Retinal venous diameters (Zeiss retinal vessel analyzer) [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
Retinal blood velocity (laser Doppler velocimetry) [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	September 2010
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 12 healthy male subjects	Other: 100% Oxygen 100% Oxygen- breathing over 30 minutes

Eligibility

Ages Eligible for Study:	19 Years to 35 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431600

Contacts

Contact: Gerhard Garhoefer, MD

0043 1 40400 ext 2981

gerhard.garhoefer@meduniwien.ac.at

Locations

Austria
Department of Clinical Pharmacology	Recruiting
Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Gerhard Garhoefer, MD

Department of Clinical Pharmacology Medical University of Vienna

More Information

No publications provided

Responsible Party:	Gabriele Fuchsjaeger-Mayrl, MD, Department of Clinical Pharmacology, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00431600 History of Changes
Other Study ID Numbers:	OPHT-121103
Study First Received:	February 5, 2007
Last Updated:	July 30, 2010
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:

Regional Blood Flow
Color Doppler Optical Coherence Tomography
CDOCT
Retinal Blood Flow

Hyperoxia
Vasoconstriction
Laser Doppler Velocimetry
Retinal Vessel Analyzer

Additional relevant MeSH terms:

Hyperoxia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012