Completed

Effect of Nitric Oxide and Prostaglandins Inhibition on Retinal Vessels Diameter During Hypoxia

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Study Aim

This study aims to observe how the diameter of retinal blood vessels changes when exposed to different interventions involving nitric oxide and prostaglandins inhibition during hypoxia (low oxygen levels).

What is being tested

COX inhibitor

+ L-NG-monomethyl arginine citrate

+ COX inhibitor + L-NG-monomethyl arginine citrate

Other
Who is being recruted

Autoimmune Diseases+5

+ Diabetes Mellitus

+ Endocrine System Diseases

From 20 to 65 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorUniversity of Aarhus
Last updated: October 16, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

This study focuses on understanding how the diameter of blood vessels in the retina, the light-sensitive tissue at the back of the eye, changes during low oxygen levels or hypoxia. It particularly explores whether blocking nitric oxide and/or prostaglandins, natural substances in the body, affects these diameter changes. The research targets individuals with healthy eyes to better understand these processes in a basic science context. This study holds importance as it may reveal new insights about how the eye responds to low oxygen levels, potentially improving the care for conditions associated with such changes, like certain eye diseases.

NCT01689090
Principal SponsorUniversity of Aarhus
Last updated: October 16, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

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

58 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusEndocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus, Type 1

Criteria

2 inclusion criteria required to participate
Diabetes type 1 without retinopathy
Diabetic retinopathy
5 exclusion criteria prevent from participating
Cardio-vascular disease
Lung disease
Pregnancy
Previous ocular disease other than retinal branch vein occlusion
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Ophthalmology, Aarhus University Hospital

Aarhus, DenmarkOpen Department of Ophthalmology, Aarhus University Hospital in Google Maps
CompletedOne Study Center