Retinal OxygenationPhase 4NCT01692821
Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation
A Phase 4 study testing 100% oxygen breathing, 15% oxygen in N2 breathing and 12% oxygen in N2 breathing in people with Retinal Oxygenation and Retinal Blood Flow, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Adequate perfusion and oxygenation is essential for the function of the inner retina. Although it is known that oxygen tension is very well autoregulated in the retina, the physiological mechanisms behind this regulation process are not fully explored. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Oxygenation, Retinal Blood Flow
- What is being tested?
- 100% oxygen breathing, 15% oxygen in N2 breathing and 12% oxygen in N2 breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2012to Jan 2013
- Phase
- Phase 4
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged between 18 and 35 years
- Nonsmokers
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 3 Dpt.
Who cannot join
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence of any form of anemia
- Blood donation during the previous 3 weeks
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, State of Vienna, 1090
About this study
Adequate perfusion and oxygenation is essential for the function of the inner retina. Although it is known that oxygen tension is very well autoregulated in the retina, the physiological mechanisms behind this regulation process are not fully explored. The development of new instruments for the non-invasive measurement of oxygen tension in retinal vessels now allows for the more precise investigation of these physiological processes. The current study seeks to evaluate the retinal oxygen saturation in healthy subjects while breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.
- Conditions
- Retinal Oxygenation, Retinal Blood Flow
- Being tested
- 100% oxygen breathing, 15% oxygen in N2 breathing, 12% oxygen in N2 breathing
- Keywords
- retinal oxygen saturation, retinal blood flow, hyperoxia, hypoxia
- Medical subject headings
- Hyperoxia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% oxygen breathingDrug
100% oxygen breathing - 30 minutes
15% oxygen in N2 breathingDrug
15% oxygen in N2 breathing - 30 minutes
12% oxygen in N2 breathingDrug
12% oxygen in N2 breathing - 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 100% oxygen breathing | Experimental | Not described Receives: Drug: 100% oxygen breathing |
| 15% oxygen in N2 breathing | Experimental | Not described Receives: Drug: 15% oxygen in N2 breathing |
| 12% oxygen in N2 breathing | Experimental | Not described Receives: Drug: 12% oxygen in N2 breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal oxygen saturation
Measured: On the study day - during each breathing period (6 times)
Secondary outcomes (1)
Retinal blood flow
Measured: On the study day - during each breathing period (6 times)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal OxygenationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
- Investigators
- Gerhard Garhöfer, Assoc. Prof. Priv.-Doz. Dr., Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692821
- Sponsor's protocol ID
- OPHT-180312
- Status last verified
- Jan 2013
- First submitted
- 14 Jun 2012
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Palkovits S, Lasta M, Told R, Schmidl D, Boltz A, Napora KJ, Werkmeister RM, Popa-Cherecheanu A, Garhofer G, Schmetterer L. Retinal oxygen metabolism during normoxia and hyperoxia in healthy subjects. Invest Ophthalmol Vis Sci. 2014 Jul 11;55(8):4707-13. doi: 10.1167/iovs.14-14593.
PubMed 25015353
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation
- ClinicalTrials.gov ID
- NCT01692821
- Acronym / sponsor ID
- OPHT-180312
- Conditions
- Retinal Oxygenation, Retinal Blood Flow
- Keywords
- retinal oxygen saturation, retinal blood flow, hyperoxia, hypoxia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Sep 2012 (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.
Adequate perfusion and oxygenation is essential for the function of the inner retina. Although it is known that oxygen tension is very well autoregulated in the retina, the physiological mechanisms behind this regulation process are not fully explored. The development of new instruments for the non-invasive measurement of oxygen tension in retinal vessels now allows for the more precise investigation of these physiological processes. The current study seeks to evaluate the retinal oxygen saturation in healthy subjects while breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100% oxygen breathing | Experimental | Drug: 100% oxygen breathing |
| 15% oxygen in N2 breathing | Experimental | Drug: 15% oxygen in N2 breathing |
| 12% oxygen in N2 breathing | Experimental | Drug: 12% oxygen in N2 breathing |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women aged between 18 and 35 years
- Nonsmokers
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 3 Dpt.
Key exclusion criteria (5 listed)
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence of any form of anemia
- Blood donation during the previous 3 weeks
- Pregnancy
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 |
|---|---|---|
| 100% oxygen breathing100% oxygen breathing - 30 minutes | Drug | 100% oxygen breathing |
| 15% oxygen in N2 breathing15% oxygen in N2 breathing - 30 minutes | Drug | 15% oxygen in N2 breathing |
| 12% oxygen in N2 breathing12% oxygen in N2 breathing - 30 minutes | Drug | 12% oxygen in N2 breathing |
Primary outcome
Retinal oxygen saturation
Time frame: On the study day - during each breathing period (6 times)
1 secondary outcome
Retinal blood flow
Time frame: On the study day - during each breathing period (6 times)
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 30 Jan 2013.
- Derived from this study: PubMed 25015353Palkovits S, Lasta M, Told R, Schmidl D, Boltz A, Napora KJ, Werkmeister RM, Popa-Cherecheanu A, Garhofer G, Schmetterer L. Retinal oxygen metabolism during normoxia and hyperoxia in healthy subjects. Invest Ophthalmol Vis Sci. 2014 Jul 11;55(8):4707-13. doi: 10.1167/iovs.14-14593.
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.
Gerhard Garhöfer, Assoc. Prof. Priv.-Doz. Dr. principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 100% oxygen breathing, 15% oxygen in N2 breathing and 12% oxygen in N2 breathing in people with Retinal Oxygenation and Retinal Blood Flow, run by Medical University of Vienna at 1 site in Austria.
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 5 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 30 Jan 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Retinal oxygen saturation (time frame: On the study day - during each breathing period (6 times)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692821, which also lists 1 linked publication.
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 30 Jan 2013.