NCT01771770

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

1.5 years

First QC Date

January 16, 2013

Last Update Submit

December 10, 2013

Conditions

Healthy

Keywords

retinal venous pressure (RVP)chronically reduced ambient pressureoxygen partial pressuremountain sickness

Outcome Measures

Primary Outcomes (1)

  • Quantify the changes in the retinal venous pressure (RVP).

    Quantify the changes in the retinal venous pressure (RVP)

    1-2 months

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy volunteers

You may qualify if:

  • healthy

You may not qualify if:

  • eye diseases
  • systemic diseases
  • term medication (except contraceptives)
  • pregnancy
  • allergies to the ingredients Alcain, Tropicamide and Phenylephrine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel, Dept. of Ophthalmology

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Josef Flammer, MD

    University of Basel, Dept. of Ophthalmology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 18, 2013

Study Start

December 1, 2011

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

CH(1)