The Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia

Retinal Hypoxia Clinical Trial

Official title:

The Underlying Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059018
• Other study ID #: HypNOCOX-2
• Secondary ID: 1-10-72-14-14
• Status: Completed
• Phase: N/A
• First received: February 7, 2014
• Last updated: August 17, 2015
• Start date: February 2014
• Est. completion date: August 2015

Study information

• Verified date: January 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Retinal Hypoxia

Intervention

Drug:
• COX-inhibitor
Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated
• Nitroglycerin
Oral administration of tablet nitroglycerin 0,5mg 5 minutes before recordings of diameter changes of retinal vessels are initiated
• COX-inhibitor + Nitroglycerin
Combination of COX-inhibitor and nitroglycerin interventions.

Locations

Country	Name	City	State
Denmark	Department of Ophtalmology, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diameter changes of retinal vessels	Comparing the differences of diameter changes occuring during each of interventions	Examination day 1 and 2	No