The Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia

Not Applicable

Completed

• Conditions: Retinal Hypoxia
• Interventions: Drug: COX-inhibitor; Drug: Nitroglycerin; Drug: COX-inhibitor + Nitroglycerin

• Registration Number: NCT02059018
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-01
• Study Start: 2014-02
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-11
• Primary Completion: 2015-02
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age between >19 and <61 years
• No known systemic or ocular diseases

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normoxia	COX-inhibitor + Nitroglycerin	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
Hypoxia	COX-inhibitor	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
Normoxia	COX-inhibitor	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
Hypoxia	COX-inhibitor + Nitroglycerin	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
Hypoxia	Nitroglycerin	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
Normoxia	Nitroglycerin	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

Primary Outcome Measures

Name	Time	Method
Diameter changes of retinal vessels	Examination day 1 and 2	Comparing the differences of diameter changes occuring during each of interventions

Trial Locations

Locations (1)

Department of Ophtalmology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark