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Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation

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ClinicalTrials.gov Identifier: NCT01692821
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : January 30, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Retinal Oxygenation Retinal Blood Flow Drug: 100% oxygen breathing Drug: 15% oxygen in N2 breathing Drug: 12% oxygen in N2 breathing Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation
Study Start Date : June 2012
Primary Completion Date : December 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 100% oxygen breathing Drug: 100% oxygen breathing
100% oxygen breathing - 30 minutes
Experimental: 15% oxygen in N2 breathing Drug: 15% oxygen in N2 breathing
15% oxygen in N2 breathing - 30 minutes
Experimental: 12% oxygen in N2 breathing Drug: 12% oxygen in N2 breathing
12% oxygen in N2 breathing - 30 minutes


Outcome Measures

Primary Outcome Measures :
  1. Retinal oxygen saturation [ Time Frame: On the study day - during each breathing period (6 times) ]

Secondary Outcome Measures :
  1. Retinal blood flow [ Time Frame: On the study day - during each breathing period (6 times) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692821


Locations
Austria
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Garhöfer, Assoc. Prof. Priv.-Doz. Dr. Department of Clinical Pharmacology, Medical University of Vienna
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerhard Garhofer, Assoc. Prof. Priv.-Doz. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01692821     History of Changes
Other Study ID Numbers: OPHT-180312
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013

Keywords provided by Gerhard Garhofer, Medical University of Vienna:
retinal oxygen saturation
retinal blood flow
hyperoxia
hypoxia

Additional relevant MeSH terms:
Hypoxia
Hyperoxia
Signs and Symptoms, Respiratory
Signs and Symptoms