REtinaL Imaging & Ambulatory BLood PrEssure

NCT ID: NCT04118205

Last Updated: 2022-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

591 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-20

Study Completion Date

2021-05-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension Blood Pressure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Optos, PLC

INDUSTRY

Sponsor Role collaborator

NHS Lothian

OTHER_GOV

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Centre, Western General Hospital

Edinburgh, City Of Edinburgh, United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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AC18080

Identifier Type: -

Identifier Source: org_study_id

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