NCT01771757

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

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
11 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

2.4 years

First QC Date

October 24, 2012

Last Update Submit

July 18, 2014

Conditions

Healthy

Keywords

retinal venous pressurereduced ambient pressureoxygen partial pressureshort-term hypoxic changes

Outcome Measures

Primary Outcomes (1)

  • Retinal venous pressure

    Quantify the changes in the retinal venous pressure (RVP)

    1 hour

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
  • blood pressure levels except standard (\<60 /\> 140 mmHg)
  • oxygen saturation (SO2) \<90%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel, Dept. of Ophthalmology

Basel, 4031, Switzerland

Location

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

October 24, 2012

First Posted

January 18, 2013

Study Start

December 1, 2011

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

July 21, 2014

Record last verified: 2014-07

Locations

CH(1)