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Completed

NCT Number: NCT01689090

Diameter Changes of Retinal Vessels During Hypoxia

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.

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Key information

Conditions

Diabetes Mellitus Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Maculopathy Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COX inhibitor

Other

Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated

Other names: Eye drops voltaren 1 mg/ml

L-NG-monomethyl arginine citrate

Other

Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels

Other names: L-NMMA

COX inhibitor + L-NG-monomethyl arginine citrate

Other

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

Primary outcomes

  1. Diameter changes of retinal vessels

    Time frame: Examination day 1 and 2

    Comparing the differences of diameter changes occuring during each of the interventions.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 20, 2012
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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