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

NCT00991900 | Withdrawn DMC

• 1 other identifier: OPHT-030409
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Physiology

Outcome Measures

Primary Outcomes (1)

• Coefficients of variation of oxygen measurement

  5 measurements on both study days

Study Arms (1)

Healthy subjects

Device: Measurement of oxygen saturation of retinal vessels with optical reflectometer

Interventions

Measurement of oxygen saturation of retinal vessels with optical reflectometer DEVICE

5 repeated measurements on both study days

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

20 healthy volunteers will be included.

You may qualify if:

• Men and Women aged between 18 and 35 years,
• Nonsmokers
• Body mass index between 15th and 85th percentile
• Normal ophthalmic findings, ametropia \< 3 Dpt.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof.Dr.med.

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 8, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 11, 2018

Record last verified: 2018-06

Locations

AU (1)