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

Withdrawn

• Conditions: Ocular Physiology
• Interventions: Device: Measurement of oxygen saturation of retinal vessels with optical reflectometer

• Registration Number: NCT00991900
• Lead Sponsor: Medical University of Vienna

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 available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2009-10
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-07
• Study First Posted: 2009-10-08
• Study Completion: 2009-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-07
• Last Update Posted: 2018-06-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Measurement of oxygen saturation of retinal vessels with optical reflectometer	-

Primary Outcome Measures

Name	Time	Method
Coefficients of variation of oxygen measurement	5 measurements on both study days

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria