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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00991900
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Duration (Months): 4
• Patients Per Site Per Month: 0

Study Details

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	Phase
Ocular Physiology	Device: Measurement of oxygen saturation of retinal vessels with optical reflectometer

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Other
• 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: Aug 1, 2009
• Anticipated Primary Completion Date: Oct 1, 2009
• Anticipated Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	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 [5 measurements on both study days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gerhard Garhofer, Ass.Prof.Dr.med., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT00991900
• Other Study ID Numbers: OPHT-030409
• First Posted: Oct 8, 2009
• Last Update Posted: Jun 11, 2018
• Last Verified: Jun 1, 2018

Study Results

No Results Posted as of Jun 11, 2018