Back to resultsEffect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation
Primary Purpose
Retinal Oxygenation, Retinal Blood Flow
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
100% oxygen breathing
15% oxygen in N2 breathing
12% oxygen in N2 breathing
Sponsored by
About this trial
This is an interventional basic science trial for Retinal Oxygenation focused on measuring retinal oxygen saturation, retinal blood flow, hyperoxia, hypoxia
Eligibility 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
Sites / Locations
- Medical University of Vienna, Department of Clinical Pharmacology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
100% oxygen breathing
15% oxygen in N2 breathing
12% oxygen in N2 breathing
Arm Description
Outcomes
Primary Outcome Measures
Retinal oxygen saturation
Secondary Outcome Measures
Retinal blood flow
Full Information
NCT ID
NCT01692821
First Posted
June 14, 2012
Last Updated
January 29, 2013
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01692821
Brief Title
Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation
Official Title
Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Oxygenation, Retinal Blood Flow
Keywords
retinal oxygen saturation, retinal blood flow, hyperoxia, hypoxia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
100% oxygen breathing
Arm Type
Experimental
Arm Title
15% oxygen in N2 breathing
Arm Type
Experimental
Arm Title
12% oxygen in N2 breathing
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
100% oxygen breathing
Intervention Description
100% oxygen breathing - 30 minutes
Intervention Type
Drug
Intervention Name(s)
15% oxygen in N2 breathing
Intervention Description
15% oxygen in N2 breathing - 30 minutes
Intervention Type
Drug
Intervention Name(s)
12% oxygen in N2 breathing
Intervention Description
12% oxygen in N2 breathing - 30 minutes
Primary Outcome Measure Information:
Title
Retinal oxygen saturation
Time Frame
On the study day - during each breathing period (6 times)
Secondary Outcome Measure Information:
Title
Retinal blood flow
Time Frame
On the study day - during each breathing period (6 times)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhöfer, Assoc. Prof. Priv.-Doz. Dr.
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
25015353
Citation
Palkovits S, Lasta M, Told R, Schmidl D, Boltz A, Napora KJ, Werkmeister RM, Popa-Cherecheanu A, Garhofer G, Schmetterer L. Retinal oxygen metabolism during normoxia and hyperoxia in healthy subjects. Invest Ophthalmol Vis Sci. 2014 Jul 11;55(8):4707-13. doi: 10.1167/iovs.14-14593.
Results Reference
derived
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Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation
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