ERG Under HypoxiaNCT01246024
Influence of Hypoxia on Electroretingraphy (ERG) Measurements
A study testing ERG in people with ERG Under Hypoxia, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
To investigate the influence of induced hypoxia on the ERG. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- ERG Under Hypoxia
- What is being tested?
- ERG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Apr 2013
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects
Who cannot join
- under 18 and over 80 years, respiratory diseases, cataracta and corneal hazes, myopia more than 6 dpt, hyperopia more than 3 dpt, allergy for any topical anesthetics in ophthalmology, photic epilepsy, asthma bronchiale.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Centre for Ophthalmology
Tübingen, D-72076
Andreas Schatz, +70712987461, schatzweb@gmail.com
About this study
To investigate the influence of induced hypoxia on the ERG.
- Conditions
- ERG Under Hypoxia
- Being tested
- ERG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERGDevice
scotopic and photopic ERG
| Study group | Role | What they receive |
|---|---|---|
| Hypoxia | Experimental | Not described Receives: Device: ERG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroretingraphy Measurements
Measured: 01.02.2011-01.06.2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startFeb 2011
- Primary completionApr 2011 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERG Under HypoxiaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246024
- Sponsor's protocol ID
- THS0001
- Status last verified
- Nov 2010
- First submitted
- 22 Nov 2010
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Hypoxia on Electroretingraphy (ERG) Measurements
- ClinicalTrials.gov ID
- NCT01246024
- Acronym / sponsor ID
- THS0001
- Conditions
- ERG Under Hypoxia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 23 Nov 2010 (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.
To investigate the influence of induced hypoxia on the ERG.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoxia | Experimental | Device: ERG |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (1 listed)
- under 18 and over 80 years, respiratory diseases, cataracta and corneal hazes, myopia more than 6 dpt, hyperopia more than 3 dpt, allergy for any topical anesthetics in ophthalmology, photic epilepsy, asthma bronchiale.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERGscotopic and photopic ERG | Device | Hypoxia |
Primary outcome
Electroretingraphy Measurements
Time frame: 01.02.2011-01.06.2011
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERG in people with ERG Under Hypoxia, run by University Hospital Tuebingen at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 23 Nov 2010. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian Gekeler, Prof. Dr. med. (+4970712987461, fgekeler@googlemail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroretingraphy Measurements (time frame: 01.02.2011-01.06.2011). 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 23 Nov 2010.