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.

Study Overview

• Status: Withdrawn
• Conditions: Ocular Physiology
• Intervention / Treatment: Device: Measurement of oxygen saturation of retinal vessels with optical reflectometer

• Study Type: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	5 measurements on both study days

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

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