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Clinical Trials/NCT01771835
NCT01771835CompletedNot Applicable

Measurement of Retinal Venous Pressure and Endothelin-1 in Patients With Diabetes Mellitus

University Hospital, Basel, Switzerland1 site in 1 country20 target enrollmentStarted: August 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Quantification of retinal venous pressure (RVP)

Study Overview

Brief Summary

Measurement of the circulation in patients with diabetes mellitus and establish a link between retinal venous pressure (RVP) and endothelin (ET-1)levels.

Detailed Description

Diabetic retinopathy and maculopathy are the main causes of visual loss. Hyperglycemia as the main risk factor of diabetic retinopathy induced damage to retinal capillaries. These in turn lead to hypoxia in the tissue and promote the release of VEGF (vascular endothelial growth factor) , which in turn increases the vascular pathology. Simultaneously, there is an increased expression of endothelin (ET-1). Endothelin increases vascular tone and regulates the micro-and macro-vascular remodeling.

In ocular blood flow perfusion pressure plays an important role. While in healthy eyes a spontaneous retinal venous pulsation is frequently observed, this is significantly less frequent in diseased eyes. An increased venous pressure lowers the ocular perfusion pressure, and increases the transmural pressure. A measurement of the retinal venous pressure and the hormone ET-1 in the blood will give us a better knowledge of the circulatory changes and their relationship to diabetes.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • diabetes mellitus type I or II
  • no diabetic retinopathy

Exclusion Criteria

  • known diabetic retinopathy
  • acute or chronic inflammation of the eyes
  • narrow angle glaucoma

Outcomes

Primary Outcomes

Quantification of retinal venous pressure (RVP)

Time Frame: 30 minutes

Secondary Outcomes

  • Quantification of ET-1 in correlation with RVP(30 minutes)

Investigators

Sponsor
University Hospital, Basel, Switzerland
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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