Diameter Changes of Retinal Vessels During Hypoxia

University of Aarhus

Status: Completed

Conditions: Diabetes Mellitus Type 1; Diabetic Maculopathy

Treatments: Other: COX inhibitor + L-NG-monomethyl arginine citrate; Other: L-NG-monomethyl arginine citrate; Other: COX inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT01689090

HypNOCOX

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Hypoxia

Experimental group

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 at two examination days.

Treatment:

Other: COX inhibitor

Other: COX inhibitor + L-NG-monomethyl arginine citrate

Other: L-NG-monomethyl arginine citrate

Normoxia

Experimental group

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 at two examination days.

Treatment:

Other: COX inhibitor

Other: COX inhibitor + L-NG-monomethyl arginine citrate

Other: L-NG-monomethyl arginine citrate