The Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia

August 17, 2015 updated by: University of Aarhus

The Underlying Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Ophtalmology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: COX-inhibitor
Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated
Other Names:
  • Eye drops diclofenac 1mg/ml
  • Voltaren eye drops
Drug: Nitroglycerin
Oral administration of tablet nitroglycerin 0,5mg 5 minutes before recordings of diameter changes of retinal vessels are initiated
Other Names:
  • Glyceryl Nitrate
Drug: COX-inhibitor + Nitroglycerin
Combination of COX-inhibitor and nitroglycerin interventions.
Experimental: 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
Drug: COX-inhibitor
Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated
Other Names:
  • Eye drops diclofenac 1mg/ml
  • Voltaren eye drops
Drug: Nitroglycerin
Oral administration of tablet nitroglycerin 0,5mg 5 minutes before recordings of diameter changes of retinal vessels are initiated
Other Names:
  • Glyceryl Nitrate
Drug: COX-inhibitor + Nitroglycerin
Combination of COX-inhibitor and nitroglycerin interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diameter changes of retinal vessels
Time Frame: Examination day 1 and 2
Comparing the differences of diameter changes occuring during each of interventions
Examination day 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Line Pedersen, MD, Aarhus University Hospital
  • Principal Investigator: Musa Kaya, stud.med, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HypNOCOX-2
  • 1-10-72-14-14 (Other Identifier: Local ethical committe for medical science)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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