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Clinical Trials/NCT01753648
NCT01753648
Unknown
Not Applicable

Non-invasive Measurement of Retinal Blood Flow Based on Vessel Analysis and Fourier Domain Optical Coherence Tomography in Patients With Hypertensive Retinopathy

Medical University of Vienna1 site in 1 country60 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertensive Retinopathy
Sponsor
Medical University of Vienna
Enrollment
60
Locations
1
Primary Endpoint
Total retinal blood flow
Last Updated
4 years ago

Overview

Brief Summary

Recently, a new and sophisticated method for assessment of retinal blood flow and retinal blood flow velocity profiles has become available. This technique is based on the combination of measurement of retinal vessel calibers with bidirectional Fourier domain optical coherence tomography (FDOCT). The valid measurement of retinal blood flow is of significant importance, because it is known that major ophthalmic diseases, such as hypertensive retinopathy, are associated with alterations in blood flow.

Hypertensive retinopathy is the most common manifestation of arterial hypertension in the eye. Elevated systemic blood pressure leads to generalized arteriolar narrowing caused by vasospasms and increased vascular tone. Further in the disease process, focal arteriolar narrowing, retinal haemorrhages, hard exudates and cotton wool spots can occur. Previous studies have shown that blood flow in the extraocular vessels and in the choroid is compromised in patients with arterial hypertension. However, data on the impact of arterial hypertension on retinal blood flow and retinal blood flow velocities are lacking.

The present study sets out to compare total retinal blood flow and retinal velocity profiles in patients with hypertensive retinopathy and healthy age- and sex-matched controls. Ocular perfusion pressure will be calculated based on measurements of blood pressure and intraocular pressure to allow for calculation of vascular resistance. In addition, velocity profiles at arterio-venous crossings will be measured. It is hypothesized that these velocity profiles are considerably modified in patients with stage 2 and 3 hypertensive retinopathy compared to healthy controls because of pronounced arterio-venous compression.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
December 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gerhard Garhofer

Assoc. Prof. PD Dr.

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria for healthy subjects
  • Men and women aged over 18 years
  • Non-smokers
  • Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
  • Systolic Blood Pressure ≤ 120 mmHg and Diastolic Blood Pressure ≤ 80 mmHg
  • Normal ophthalmic findings, ametropia \< 6 Dpt.
  • Inclusion criteria for patients with hypertensive retinopathy
  • Men and women aged over 18 years
  • Hypertensive retinopathy stage 2 or 3
  • Normal ophthalmic findings except hypertensive retinopathy stage 2 and 3, ametropia \< 6 Dpt.

Exclusion Criteria

  • Any of the following will exclude a healthy subject from the study:
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Presence or history of a severe medical condition as judged by the clinical investigator
  • Presence or history of arterial hypertension
  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
  • Blood donation during the previous three weeks
  • Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
  • Ametropia \>= 6 Dpt
  • Pregnancy, planned pregnancy or lactating
  • Any of the following will exclude a patient with hypertensive retinopathy from the study:

Outcomes

Primary Outcomes

Total retinal blood flow

Time Frame: 1 day

Secondary Outcomes

  • Ocular perfusion pressure(1 day)
  • Retinal (arterial and venous) oxygen saturation(1 day)
  • Retinal vessel diameter(1 day)
  • Retinal blood velocities(1 day)

Study Sites (1)

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