REtinaL Imaging & Ambulatory BLood PrEssure

NCT04118205 | Completed

• 1 other identifier: AC18080
• Study Type: observational
• Target: 591
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Does retinal arteriovenous ratio correlate to clinic systolic blood pressure

  1 day

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants attending a hypertensive clinic at the Western General Hospital in Edinburgh will be asked to consent to ultra-wide field retinal imaging, subject to the inclusion and exclusion criteria below. It is expected that between 25 and 50 participants per week attend the clinic, of which approximately 50% are attending without a known diagnosis of hypertension.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• Optos, PLC: collaborator
• NHS Lothian: collaborator

Study Sites (1)

Clinical Research Centre, Western General Hospital

Edinburgh, City Of Edinburgh, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 8, 2019
• Study Start: January 20, 2019
• Primary Completion: December 9, 2019
• Study Completion: May 4, 2021
• Last Updated: March 14, 2022

Record last verified: 2020-03

Locations

GB (1)