HealthyNCT01771770
Measurement of Retinal Venous Pressure in Chronic Low-oxygen Environment
An observational study of Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy volunteers
Who may be able to join
- healthy
Who cannot join
- eye diseases
- systemic diseases
- term medication (except contraceptives)
- pregnancy
- allergies to the ingredients Alcain, Tropicamide and Phenylephrine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of the Retinal Venous Pressure (RVP) Under Conditions of Chronically Reduced Ambient Pressure and Oxygen Partial Pressure (Field Study)
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.
Read the detailed 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.
- Conditions
- Healthy
- Keywords
- retinal venous pressure (RVP), chronically reduced ambient pressure, oxygen partial pressure, mountain sickness
- Medical subject headings
- Altitude Sickness
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify the changes in the retinal venous pressure (RVP).
Quantify the changes in the retinal venous pressure (RVP)
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josef Flammer, MD, Study director, University of Basel, Dept. of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771770
- Sponsor's protocol ID
- USB-2011-328
- Status last verified
- Dec 2013
- First submitted
- 16 Jan 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Retinal Venous Pressure (RVP) Under Conditions of Chronically Reduced Ambient Pressure and Oxygen Partial Pressure (Field Study)
- ClinicalTrials.gov ID
- NCT01771770
- Acronym / sponsor ID
- USB-2011-328
- Conditions
- Healthy
- Keywords
- retinal venous pressure (RVP), chronically reduced ambient pressure, oxygen partial pressure, mountain sickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteers
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (5 listed)
- eye diseases
- systemic diseases
- term medication (except contraceptives)
- pregnancy
- allergies to the ingredients Alcain, Tropicamide and Phenylephrine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantify the changes in the retinal venous pressure (RVP).
Time frame: 1-2 months
Quantify the changes in the retinal venous pressure (RVP)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Flammer, MD study director
University of Basel, Dept. of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify the changes in the retinal venous pressure (RVP). (time frame: 1-2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.