Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2012-11-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Hypoxia
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 at two examination days.
COX inhibitor
Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated
L-NG-monomethyl arginine citrate
Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels
COX inhibitor + L-NG-monomethyl arginine citrate
Combination of interventions. Administration of an eye drop voltaren and 45 minutes later infusion with L-NMMA is started and recording of diameter changes of retinal vessels is performed
Normoxia
Breathing atmospheric air during recordings of diameter changes of retinal vessels. Recording are performed during normoxia alone and in combination with the associated interventions at two examination days.
COX inhibitor
Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated
L-NG-monomethyl arginine citrate
Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels
COX inhibitor + L-NG-monomethyl arginine citrate
Combination of interventions. Administration of an eye drop voltaren and 45 minutes later infusion with L-NMMA is started and recording of diameter changes of retinal vessels is performed
Interventions
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COX inhibitor
Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated
L-NG-monomethyl arginine citrate
Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels
COX inhibitor + L-NG-monomethyl arginine citrate
Combination of interventions. Administration of an eye drop voltaren and 45 minutes later infusion with L-NMMA is started and recording of diameter changes of retinal vessels is performed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diabetic retinopathy
Exclusion Criteria
* Lung disease
* Pregnancy
* Previous ocular disease other than retinal branch vein occlusion
* Previous treatment with medications influencing on the intraocular pressure or the metabolism of nitric oxide or prostaglandins
20 Years
65 Years
ALL
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Line Pedersen, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Department of Ophthalmology, Aarhus University Hospital
Aarhus, , Denmark
Countries
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References
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Petersen L, Bek T. Post-hypoxic constriction of retinal arterioles is impaired during nitric oxide and cyclo-oxygenase inhibition and in diabetic patients without retinopathy. Graefes Arch Clin Exp Ophthalmol. 2017 Oct;255(10):1965-1971. doi: 10.1007/s00417-017-3746-2. Epub 2017 Jul 27.
Petersen L, Bek T. The diameter response of retinal arterioles in diabetic maculopathy is reduced during hypoxia and is unaffected by the inhibition of cyclo-oxygenase and nitric oxide synthesis. Graefes Arch Clin Exp Ophthalmol. 2016 Dec;254(12):2339-2346. doi: 10.1007/s00417-016-3399-6. Epub 2016 Jun 7.
Other Identifiers
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HypNOCOX
Identifier Type: -
Identifier Source: org_study_id
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