Back to resultsThe Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia
Primary Purpose
Retinal Hypoxia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
COX-inhibitor
Nitroglycerin
COX-inhibitor + Nitroglycerin
Sponsored by
About this trial
This is an interventional basic science trial for Retinal Hypoxia
Eligibility Criteria
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
Sites / Locations
- Department of Ophtalmology, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hypoxia
Normoxia
Arm Description
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
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
Outcomes
Primary Outcome Measures
Diameter changes of retinal vessels
Comparing the differences of diameter changes occuring during each of interventions
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02059018
Brief Title
The Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia
Official Title
The Underlying Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Hypoxia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypoxia
Arm Type
Experimental
Arm Description
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
Arm Title
Normoxia
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
COX-inhibitor
Other Intervention Name(s)
Eye drops diclofenac 1mg/ml, Voltaren eye drops
Intervention Description
Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Other Intervention Name(s)
Glyceryl Nitrate
Intervention Description
Oral administration of tablet nitroglycerin 0,5mg 5 minutes before recordings of diameter changes of retinal vessels are initiated
Intervention Type
Drug
Intervention Name(s)
COX-inhibitor + Nitroglycerin
Intervention Description
Combination of COX-inhibitor and nitroglycerin interventions.
Primary Outcome Measure Information:
Title
Diameter changes of retinal vessels
Description
Comparing the differences of diameter changes occuring during each of interventions
Time Frame
Examination day 1 and 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line Pedersen, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Musa Kaya, stud.med
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophtalmology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia
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