Diameter Changes of Retinal Vessels During Hypoxia

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 1; Diabetic Maculopathy
• Interventions: Other: COX inhibitor; Other: L-NG-monomethyl arginine citrate; Other: COX inhibitor + L-NG-monomethyl arginine citrate

• Registration Number: NCT01689090
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-20
• Study Start: 2012-11
• Status Verified: 2015-08
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Diabetes type 1 without retinopathy
• Diabetic retinopathy

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hypoxia	L-NG-monomethyl arginine citrate	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.
Hypoxia	COX inhibitor	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.
Normoxia	COX inhibitor	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.
Normoxia	COX inhibitor + L-NG-monomethyl arginine citrate	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.
Hypoxia	COX inhibitor + L-NG-monomethyl arginine citrate	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.
Normoxia	L-NG-monomethyl arginine citrate	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.

Primary Outcome Measures

Name	Time	Method
Diameter changes of retinal vessels	Examination day 1 and 2	Comparing the differences of diameter changes occuring during each of the interventions.

Trial Locations

Locations (1)

Department of Ophthalmology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark