Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Retinal Oxygenation Retinal Blood Flow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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100% oxygen breathing

Group Type EXPERIMENTAL

100% oxygen breathing

Intervention Type DRUG

100% oxygen breathing - 30 minutes

15% oxygen in N2 breathing

Group Type EXPERIMENTAL

15% oxygen in N2 breathing

Intervention Type DRUG

15% oxygen in N2 breathing - 30 minutes

12% oxygen in N2 breathing

Group Type EXPERIMENTAL

12% oxygen in N2 breathing

Intervention Type DRUG

12% oxygen in N2 breathing - 30 minutes

Interventions

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100% oxygen breathing

100% oxygen breathing - 30 minutes

Intervention Type DRUG

15% oxygen in N2 breathing

15% oxygen in N2 breathing - 30 minutes

Intervention Type DRUG

12% oxygen in N2 breathing

12% oxygen in N2 breathing - 30 minutes

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes