Short Term and Day to Day Reproducibility of Reflectometric Measurement of Retinal Oxygen Saturation in Healthy Subjects

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by:

Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00991900

First received: October 7, 2009

Last updated: NA

Last verified: October 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	October 7, 2009
Last Updated Date	October 7, 2009
Start Date ^ICMJE	August 2009
Estimated Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 7, 2009)	Coefficients of variation of oxygen measurement [ Time Frame: 5 measurements on both study days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Short Term and Day to Day Reproducibility of Reflectometric Measurement of Retinal Oxygen Saturation in Healthy Subjects
Official Title ^ICMJE	Short Term and Day to Day Reproducibility of Reflectometric Measurement of Retinal Oxygen Saturation in Healthy Subjects
Brief Summary	Adequate perfusion and oxygenation is essential for the function of the inner retina. Although this is a well known fact, measurement of oxygen saturation in the eye is still a delicate and not fully explored task. However, recently a new instrument for the non-invasive measurement of retinal vessel oxygen saturation has been introduced. Unfortunately, no data about reproducibility in humans is yet available for this instrument. Consequently, the current study seeks to evaluate the short term and day to day reproducibility of retinal vessel oxygenation in healthy volunteers. 20 healthy volunteers will be included and oxygen saturation of retinal vessels will be determined. The reproducibility of the results will be tested by repeated measurements and the collected data will be independently analyzed by two observers.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	20 healthy volunteers will be included.
Condition ^ICMJE	Ocular Physiology
Intervention ^ICMJE	Device: Measurement of oxygen saturation of retinal vessels with optical reflectometer 5 repeated measurements on both study days
Study Group/Cohort (s)	Healthy subjects Intervention: Device: Measurement of oxygen saturation of retinal vessels with optical reflectometer
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	Withdrawn
Estimated Enrollment ^ICMJE	20
Estimated Completion Date	December 2009
Estimated Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Men and Women aged between 18 and 35 years, Nonsmokers Body mass index between 15th and 85th percentile 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 except oral contraceptives Symptoms of a clinically relevant illness in the 3 weeks before the study day Blood donation during the previous 3 weeks
Gender	Both
Ages	18 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	NCT00991900
Other Study ID Numbers ^ICMJE	OPHT-030409
Has Data Monitoring Committee	Yes
Responsible Party	Gerhard Garhofer, Department of Clinical Pharmacology, Medical University of Vienna
Study Sponsor ^ICMJE	Medical University of Vienna
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Medical University of Vienna
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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