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NCT01689090 Clinical Trial

Diameter Changes of Retinal Vessels During Hypoxia

Diabetes Mellitus Type 1 Clinical Trial

Official title:
Diameter Changes of Retinal Vessels During Hypoxia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01689090
Other study ID # HypNOCOX
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2012
Est. completion date March 2016

Study information
Verified date August 2015
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to study if an inhibition of nitric oxide and/or prostaglandins affect the diameter changes of retinal vessels observed during hypoxia. Diameter changes are studied using the Dynamic Vessel Analyzer.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- Diabetes type 1 without retinopathy

- Diabetic retinopathy

Exclusion Criteria:

- Cardio-vascular disease

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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

Locations
Country Name City State
Denmark Department of Ophthalmology, Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diameter changes of retinal vessels Comparing the differences of diameter changes occuring during each of the interventions. Examination day 1 and 2
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