Measurement of Retinal Venous Pressure Under Short-term Low-oxygen Environment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01771757
First received: October 24, 2012
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

The hypothesis is that the pressure in the retinal veins increases under a short-term lack of oxygen and leads to a decreased blood circulation. On the basis of measurements in the hypobaric chamber this hypothesis should be verified.


Condition
Healthy

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

Resource links provided by NLM:


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

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


Enrollment: 24
Study Start Date: December 2011
Study Completion Date: July 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Conduct a pilot study to describe and quantify the retinal venous pressure (RVP) in healthy volunteers under conditions of controlled, reduced ambient and oxygen partial pressure in the pressure chamber of the Aeromedical Institute FAI in Dübendorf, Switzerland. Obtaining evidence of the adaptation behavior of the retinal vascular system in controlled, short-term hypoxic changes.

  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
  • blood pressure levels except standard (<60 /> 140 mmHg)
  • oxygen saturation (SO2) <90%
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01771757

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: NCT01771757     History of Changes
Other Study ID Numbers: USB-2011-327
Study First Received: October 24, 2012
Last Updated: July 18, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
retinal venous pressure
reduced ambient pressure
oxygen partial pressure
short-term hypoxic changes

ClinicalTrials.gov processed this record on September 16, 2014