Text Size

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

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01771757
First received: October 24, 2012
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

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)


Estimated Enrollment: 24
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771757

Contacts
Contact: Michael Baertschi, M.Sc.Optom +41 61 2658809 mbaertschi@uhbs.ch

Locations
Switzerland
University of Basel, Dept. of Ophthalmology Recruiting
Basel, Switzerland, 4031
Contact: Michael Baertschi, M.Sc.Optom     +41 61 265 8809     mbaertschi@uhbs.ch    
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: January 16, 2013
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 May 16, 2013