Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01692821
First received: June 14, 2012
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Retinal oxygen saturation [ Time Frame: On the study day - during each breathing period (6 times) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retinal blood flow [ Time Frame: On the study day - during each breathing period (6 times) ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 14, 2012
Last Updated: January 29, 2013
Health Authority: Austria: Agency for Health and Food Safety

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

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

ClinicalTrials.gov processed this record on September 15, 2014