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

This study has been completed.

Sponsor:

Information provided by:

Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00431600

First received: February 5, 2007

Last updated: September 20, 2012

Last verified: July 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

February 5, 2007

Last Updated Date

September 20, 2012

Start Date ^ICMJE

September 2010

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Retinal blood flow (LDV, RVA)
Retinal blood flow (CDOCT)

Change History

Complete list of historical versions of study NCT00431600 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain CDOCT

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)

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Other: 100% Oxygen

100% Oxygen- breathing over 30 minutes

Study Arm (s)

Experimental: 1

12 healthy male subjects

Intervention: Other: 100% Oxygen

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2012

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

19 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT00431600

Other Study ID Numbers ^ICMJE

OPHT-121103

Has Data Monitoring Committee

Yes

Responsible Party

Gabriele Fuchsjaeger-Mayrl, MD, Department of Clinical Pharmacology, Medical University of Vienna

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gerhard Garhoefer, MD

Department of Clinical Pharmacology Medical University of Vienna

Information Provided By

Medical University of Vienna

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top