The Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia

NCT ID: NCT02059018

Last Updated: 2015-08-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-08-31

Brief Summary

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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

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Conditions

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Retinal Hypoxia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

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 over two examination days

Group Type EXPERIMENTAL

COX-inhibitor

Intervention Type DRUG

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

Nitroglycerin

Intervention Type DRUG

Oral administration of tablet nitroglycerin 0,5mg 5 minutes before recordings of diameter changes of retinal vessels are initiated

COX-inhibitor + Nitroglycerin

Intervention Type DRUG

Combination of COX-inhibitor and nitroglycerin interventions.

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 over two examination days

Group Type EXPERIMENTAL

COX-inhibitor

Intervention Type DRUG

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

Nitroglycerin

Intervention Type DRUG

Oral administration of tablet nitroglycerin 0,5mg 5 minutes before recordings of diameter changes of retinal vessels are initiated

COX-inhibitor + Nitroglycerin

Intervention Type DRUG

Combination of COX-inhibitor and nitroglycerin interventions.

Interventions

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COX-inhibitor

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

Intervention Type DRUG

Nitroglycerin

Oral administration of tablet nitroglycerin 0,5mg 5 minutes before recordings of diameter changes of retinal vessels are initiated

Intervention Type DRUG

COX-inhibitor + Nitroglycerin

Combination of COX-inhibitor and nitroglycerin interventions.

Intervention Type DRUG

Other Intervention Names

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Eye drops diclofenac 1mg/ml Voltaren eye drops Glyceryl Nitrate

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Line Pedersen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Musa Kaya, stud.med

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Department of Ophtalmology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1-10-72-14-14

Identifier Type: OTHER

Identifier Source: secondary_id

HypNOCOX-2

Identifier Type: -

Identifier Source: org_study_id

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