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

June 7, 2018 updated by: Gerhard Garhofer, Medical University of Vienna

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

20 healthy volunteers will be included.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Coefficients of variation of oxygen measurement
Time Frame: 5 measurements on both study days
5 measurements on both study days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

October 7, 2009

First Posted (Estimate)

October 8, 2009

Study Record Updates

Last Update Posted (Actual)

June 11, 2018

Last Update Submitted That Met QC Criteria

June 7, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • OPHT-030409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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