Measurement of Retinal Venous Pressure in Chronic Low-oxygen Environment

Healthy Clinical Trial

Official title:

Measurement of the Retinal Venous Pressure (RVP) Under Conditions of Chronically Reduced Ambient Pressure and Oxygen Partial Pressure (Field Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771770
• Other study ID #: USB-2011-328
• Status: Completed
• Phase: N/A
• First received: January 16, 2013
• Last updated: December 10, 2013
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• healthy

Exclusion Criteria:

• eye diseases

• systemic diseases

• term medication (except contraceptives)

• pregnancy

• allergies to the ingredients Alcain, Tropicamide and Phenylephrine

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Switzerland	University of Basel, Dept. of Ophthalmology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify the changes in the retinal venous pressure (RVP).	Quantify the changes in the retinal venous pressure (RVP)	1-2 months	No