Retinal HypoxiaNCT02059018
The Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia
A study testing COX-inhibitor, Nitroglycerin and COX-inhibitor + Nitroglycerin in people with Retinal Hypoxia, run by University of Aarhus at 1 site in Denmark.
Trial summary
The primary objective is to study if a stimulation of nitric oxide and/or prostaglandin affect the diameter changes of retinal vessels during hypoxia. Diameter changes are studied using the Dynamic Vessel Analyzer. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Hypoxia
- What is being tested?
- COX-inhibitor, Nitroglycerin and COX-inhibitor + Nitroglycerin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Aug 2015
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between >19 and <61 years
- No known systemic or ocular diseases
Who cannot join
- Cardio-vascular disease
- Lung disease
- Epilepsy
- Previous ocular disease
- Previous treatment with medications influencing the intraocular pressure or the metabolism of nitric oxide or prostaglandins
- Daily intake of medicine except contraceptive pills
- Pregnancy or breastfeeding
- Known allergy against any of the drugs used in the interventions
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophtalmology, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: The Underlying Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia
The primary objective is to study if a stimulation of nitric oxide and/or prostaglandin affect the diameter changes of retinal vessels during hypoxia. Diameter changes are studied using the Dynamic Vessel Analyzer.
- Conditions
- Retinal Hypoxia
- Being tested
- COX-inhibitor, Nitroglycerin, COX-inhibitor + Nitroglycerin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COX-inhibitorDrug
Also called Eye drops diclofenac 1mg/ml, Voltaren eye drops
Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated
NitroglycerinDrug
Also called Glyceryl Nitrate
Oral administration of tablet nitroglycerin 0,5mg 5 minutes before recordings of diameter changes of retinal vessels are initiated
COX-inhibitor + NitroglycerinDrug
Combination of COX-inhibitor and nitroglycerin interventions.
| Study group | Role | What they receive |
|---|---|---|
| Hypoxia | Experimental | Inhaling hypoxic gas mixture to induce hypoxemia during recordings of diameter changes of retinal vessels. Recording are performed during hypoxia alone and in combination with the associated interventions over two examination days Receives: Drug: COX-inhibitor; Drug: Nitroglycerin; Drug: COX-inhibitor + Nitroglycerin |
| Normoxia | Experimental | Breathing atmospheric air during recordings of diameter changes of retinal vessels. Recording are performed during normoxia alone and in combination with the associated interventions over two examination days Receives: Drug: COX-inhibitor; Drug: Nitroglycerin; Drug: COX-inhibitor + Nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter changes of retinal vessels
Comparing the differences of diameter changes occuring during each of interventions
Measured: Examination day 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal HypoxiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Line Pedersen, MD, Principal investigator, Aarhus University HospitalMusa Kaya, stud.med, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059018
- Sponsor's protocol ID
- HypNOCOX-2
- Other IDs
- 1-10-72-14-14
- Status last verified
- Jan 2014
- First submitted
- 7 Feb 2014
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Underlying Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia
- ClinicalTrials.gov ID
- NCT02059018
- Acronym / sponsor ID
- HypNOCOX-2
- Conditions
- Retinal Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Feb 2014 (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 primary objective is to study if a stimulation of nitric oxide and/or prostaglandin affect the diameter changes of retinal vessels during hypoxia. Diameter changes are studied using the Dynamic Vessel Analyzer.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoxia | Experimental | Drug: COX-inhibitor, Drug: Nitroglycerin, Drug: COX-inhibitor + NitroglycerinInhaling hypoxic gas mixture to induce hypoxemia during recordings of diameter changes of retinal vessels. Recording are performed during hypoxia alone and in combination with the associated interventions over two examination days |
| Normoxia | Experimental | Drug: COX-inhibitor, Drug: Nitroglycerin, Drug: COX-inhibitor + NitroglycerinBreathing atmospheric air during recordings of diameter changes of retinal vessels. Recording are performed during normoxia alone and in combination with the associated interventions over two examination days |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between >19 and <61 years
- No known systemic or ocular diseases
Key exclusion criteria (8 listed)
- Cardio-vascular disease
- Lung disease
- Epilepsy
- Previous ocular disease
- Previous treatment with medications influencing the intraocular pressure or the metabolism of nitric oxide or prostaglandins
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 |
|---|---|---|
| COX-inhibitorAlso: Eye drops diclofenac 1mg/ml, Voltaren eye dropsAdministration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated | Drug | Hypoxia, Normoxia |
| NitroglycerinAlso: Glyceryl NitrateOral administration of tablet nitroglycerin 0,5mg 5 minutes before recordings of diameter changes of retinal vessels are initiated | Drug | Hypoxia, Normoxia |
| COX-inhibitor + NitroglycerinCombination of COX-inhibitor and nitroglycerin interventions. | Drug | Hypoxia, Normoxia |
Primary outcome
Diameter changes of retinal vessels
Time frame: Examination day 1 and 2
Comparing the differences of diameter changes occuring during each of interventions
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 19 Aug 2015.
Related trials for Retinal Hypoxia
RecruitingObservational study
Incidence of Hypoxia During Intravitreal Anti-VEGF (Vascular Endothelial Growth Factor) Injections for Retinopathy of Prematurity (ROP) Under Topical Anesthesia
Retinopathy of Prematurity
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.
Line Pedersen, MD principal investigator
Aarhus University Hospital
Musa Kaya, stud.med principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COX-inhibitor, Nitroglycerin and COX-inhibitor + Nitroglycerin in people with Retinal Hypoxia, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 8 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 19 Aug 2015. 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 Denmark. 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?
Diameter changes of retinal vessels (time frame: Examination day 1 and 2). 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 19 Aug 2015.