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Measurement of Retinal Venous Pressure in Chronic Low-oxygen Environment

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT01771770
Collaborator
(none)
40
Enrollment
1
Location
24
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    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)
    Study Start Date :
    Dec 1, 2011
    Actual Primary Completion Date :
    Jun 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Quantify the changes in the retinal venous pressure (RVP). [1-2 months]

      Quantify the changes in the retinal venous pressure (RVP)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT01771770
    Other Study ID Numbers:
    • USB-2011-328
    First Posted:
    Jan 18, 2013
    Last Update Posted:
    Dec 11, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by University Hospital, Basel, Switzerland
    retinal venous pressure (RVP)
    chronically reduced ambient pressure
    oxygen partial pressure
    mountain sickness

    Study Results

    No Results Posted as of Dec 11, 2013