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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00991900
Recruitment Status : Withdrawn
First Posted : October 8, 2009
Last Update Posted : October 8, 2009
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Ocular Physiology Device: Measurement of oxygen saturation of retinal vessels with optical reflectometer

Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
Time Perspective: Prospective
Official Title: Short Term and Day to Day Reproducibility of Reflectometric Measurement of Retinal Oxygen Saturation in Healthy Subjects
Study Start Date : August 2009
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Healthy subjects Device: Measurement of oxygen saturation of retinal vessels with optical reflectometer
5 repeated measurements on both study days


Outcome Measures

Primary Outcome Measures :
  1. Coefficients of variation of oxygen measurement [ Time Frame: 5 measurements on both study days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
20 healthy volunteers will be included.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991900


Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
More Information

Responsible Party: Gerhard Garhofer, Department of Clinical Pharmacology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00991900     History of Changes
Other Study ID Numbers: OPHT-030409
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: October 8, 2009
Last Verified: October 2009