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Completed

NCT Number: NCT01692821

Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation

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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Key information

Conditions

Retinal Oxygenation Hyperoxia Hypoxia Pathological Conditions, Signs and Symptoms Retinal Blood Flow Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

100% oxygen breathing

Drug

100% oxygen breathing - 30 minutes

15% oxygen in N2 breathing

Drug

15% oxygen in N2 breathing - 30 minutes

12% oxygen in N2 breathing

Drug

12% oxygen in N2 breathing - 30 minutes

Primary outcomes

  1. Retinal oxygen saturation

    Time frame: On the study day - during each breathing period (6 times)

Secondary outcomes

  1. Retinal blood flow

    Time frame: On the study day - during each breathing period (6 times)

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Sep 25, 2012
Registry last updated
Jan 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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