- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01771757
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
-
-
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Basel, Switzerland, 4031
- University of Basel, Dept. of Ophthalmology
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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
Keywords
Other Study ID Numbers
- USB-2011-327
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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