Measurement of Retinal Venous Pressure in Chronic Low-oxygen Environment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01771770
First received: January 16, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

The hypothesis is that the pressure in the retinal veins increases from chronic lack of oxygen and leads to decreased blood flow. On the basis of high altitude mountaineering this hypothesis should be verified. At the same time the adaptation capacity of the blood circulation should be analyzed, and a relationship ​​to mountain sickness should be found.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of the Retinal Venous Pressure (RVP) Under Conditions of Chronically Reduced Ambient Pressure and Oxygen Partial Pressure (Field Study)

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Quantify the changes in the retinal venous pressure (RVP). [ Time Frame: 1-2 months ] [ Designated as safety issue: No ]
    Quantify the changes in the retinal venous pressure (RVP)


Enrollment: 40
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Conduct a field study to describe and quantify the retinal venous pressure (RVP) in healthy volunteers under conditions of controlled chronically reduced ambient pressure and oxygen partial pressure in the mountains. Obtaining indications regarding the adaptation of the retinal vascular system behavior to controlled, long-term hypoxic changes. Comparisons with blood pressure, pulse, oxygen saturation level and the appearance of symptoms of acute mountain sickness are made in order to obtain a better understanding of the development of high altitude illness.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy volunteers

Criteria

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • eye diseases
  • systemic diseases
  • term medication (except contraceptives)
  • pregnancy
  • allergies to the ingredients Alcain, Tropicamide and Phenylephrine
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01771770

Locations
Switzerland
University of Basel, Dept. of Ophthalmology
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Director: Josef Flammer, MD University of Basel, Dept. of Ophthalmology
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01771770     History of Changes
Other Study ID Numbers: USB-2011-328
Study First Received: January 16, 2013
Last Updated: December 10, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
retinal venous pressure (RVP)
chronically reduced ambient pressure
oxygen partial pressure
mountain sickness

ClinicalTrials.gov processed this record on July 22, 2014