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This study has been withdrawn prior to enrollment.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

October 7, 2009
October 7, 2009
August 2009
October 2009   (final data collection date for primary outcome measure)
Coefficients of variation of oxygen measurement [ Time Frame: 5 measurements on both study days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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Short Term and Day to Day Reproducibility of Reflectometric Measurement of Retinal Oxygen Saturation in Healthy Subjects
Short Term and Day to Day Reproducibility of Reflectometric Measurement of Retinal Oxygen Saturation in Healthy Subjects

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.

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Observational
Time Perspective: Prospective
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Probability Sample

20 healthy volunteers will be included.

Ocular Physiology
Device: Measurement of oxygen saturation of retinal vessels with optical reflectometer
5 repeated measurements on both study days
Healthy subjects
Intervention: Device: Measurement of oxygen saturation of retinal vessels with optical reflectometer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
20
December 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00991900
OPHT-030409
Yes
Gerhard Garhofer, Department of Clinical Pharmacology, Medical University of Vienna
Medical University of Vienna
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Not Provided
Medical University of Vienna
October 2009

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