REtinaL Imaging & Ambulatory BLood PrEssure

Hypertension Clinical Trial

— RELIABLE  

Official title:

REtinaL Imaging & Ambulatory BLood PrEssure: Validating Ultra-widefield Retinal Imaging Derived Biomarkers Against Ambulatory Blood Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118205
• Other study ID #: AC18080
• Status: Completed
• Start date: January 20, 2019
• Est. completion date: May 4, 2021

Study information

• Verified date: March 2020
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

High blood pressure is a common condition which generally does not have any symptoms. Its estimated that around one third of people with high blood pressure do not know they have it. The back of the eye called the retina is one of the few places in the human body allowing easy observation of blood vessels. This study aims to see if simple non-invasive imaging of the blood vessels of the retina will highlight people with high blood pressure.

Description:

This will be a prospective, single centre study recruiting patients who are attending the ambulatory blood pressure clinic at the Western General Hospital. Suitable patients will be approached, and if they consent will have pictures of the back of each of their eyes taken. These pictures will then be reviewed, with certain measurements taken of the small blood vessels which can been seen at the back of the eye. These measurements will then be compared to the participants blood pressure readings to see if they might accurately correlate to blood pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 591
• Est. completion date: May 4, 2021
• Est. primary completion date: December 9, 2019
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Attending ambulatory blood pressure clinic

• Able to undertake ambulatory BP measurement

• Able to undertake single clinic-based BP measurement

• Able to undergo UWF retinal imaging with a SLO

• Aged 18 to 90

• Able to give informed consent

Exclusion Criteria:

• People with known history of retinal surgery

• People under the age of 18 years.

• People that cannot: manoeuvre themselves to the SLO unaided, sit upright in a chair or wheelchair or position themselves comfortably for imaging.

• People with epilepsy

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Locations

Country	Name	City	State
United Kingdom	Clinical Research Centre, Western General Hospital	Edinburgh	City Of Edinburgh

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian, Optos, PLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does retinal arteriovenous ratio correlate to systolic blood pressure	Retinal arteriovenous ratio (as measured by ultra-wide field imaging) will be correlated to mean daytime systolic blood pressure (as measured by 24-hour ambulatory blood pressure monitoring)	1 day
Secondary	Does retinal arteriovenous ratio correlate to clinic systolic blood pressure	Retinal arteriovenous ratio (as measured by ultra-wide field imaging) will be correlated to clinic systolic blood pressure.	1 day