Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation

Retinal Blood Flow Clinical Trial

Official title:

Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692821
• Other study ID #: OPHT-180312
• Status: Completed
• Phase: Phase 4
• First received: June 14, 2012
• Last updated: January 29, 2013
• Start date: June 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

Adequate perfusion and oxygenation is essential for the function of the inner retina. Although it is known that oxygen tension is very well autoregulated in the retina, the physiological mechanisms behind this regulation process are not fully explored. The development of new instruments for the non-invasive measurement of oxygen tension in retinal vessels now allows for the more precise investigation of these physiological processes. The current study seeks to evaluate the retinal oxygen saturation in healthy subjects while breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Men and women aged between 18 and 35 years

• Nonsmokers

• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

• Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant

• Normal ophthalmic findings, ametropy < 3 Dpt.

Exclusion Criteria:

• Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)

• Symptoms of a clinically relevant illness in the 3 weeks before the first study day

• Presence of any form of anemia

• Blood donation during the previous 3 weeks

• Pregnancy

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperoxia
• Retinal Blood Flow
• Retinal Oxygenation

Intervention

Drug:
• 100% oxygen breathing
100% oxygen breathing - 30 minutes
• 15% oxygen in N2 breathing
15% oxygen in N2 breathing - 30 minutes
• 12% oxygen in N2 breathing
12% oxygen in N2 breathing - 30 minutes

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal oxygen saturation		On the study day - during each breathing period (6 times)	No
Secondary	Retinal blood flow		On the study day - during each breathing period (6 times)	No