Diameter Changes of Retinal Vessels During Hypoxia

October 11, 2018 updated by: University of Aarhus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

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 Ophthalmology, 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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 at two examination days.
Other: COX inhibitor
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
Other: L-NG-monomethyl arginine citrate
Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels
Other Names:
  • L-NMMA
Other: 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
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 at two examination days.
Other: COX inhibitor
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
Other: L-NG-monomethyl arginine citrate
Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels
Other Names:
  • L-NMMA
Other: 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

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 the 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimate)

September 20, 2012

Study Record Updates

Last Update Posted (Actual)

October 16, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HypNOCOX

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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