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

July 18, 2014 updated by: University Hospital, Basel, Switzerland

Measurement of Retinal Venous Pressure (Retinal Venous Pressure RVP) Under Conditions of Reduced Ambient Pressure and Oxygen Partial Pressure

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Basel, Switzerland, 4031
        • University of Basel, Dept. of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy volunteers

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal venous pressure
Time Frame: 1 hour
Quantify the changes in the retinal venous pressure (RVP)
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Josef Flammer, MD, University of Basel, Dept. of Ophthalmology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

October 24, 2012

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

July 21, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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