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

Hypertensive Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01753648
• Other study ID #: OPHT-220612
• Status: Recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: Gerhard Garhoefer, MD
• Phone: +43140400
• Email: gerhard.garhoefer[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• Participation in a clinical trial in the 3 weeks preceding the screening visit

• 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

• Blood donation during the previous three weeks

• Hypertensive retinopathy stage 4

• Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator

• Ametropia >= 6 Dpt

• Pregnancy, planned pregnancy or lactating

Related Conditions & MeSH terms

• Hypertensive Retinopathy
• Retinal Diseases

Intervention

Device:
• Dynamic Vessel Analyzer
Retinal vessel diameter, total retinal blood flow (together with FD-OCT), retinal oxygen saturation

Other:
• FDOCT
total retinal blood flow (together with DVA), retinal blood velocities
• Ocular perfusion pressure
Measurement of intraocular pressure and mean arterial blood pressure for determination of ocular perfusion pressure

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total retinal blood flow		1 day
Secondary	Retinal vessel diameter		1 day
Secondary	Retinal blood velocities		1 day
Secondary	Ocular perfusion pressure		1 day
Secondary	Retinal (arterial and venous) oxygen saturation		1 day