Hypertension Clinical Trial
Official title:
Assessment of Retinal Vasculature Using Optical Coherence Tomography in Health, Hypertension & Chronic Kidney Disease.
NCT number | NCT02132741 |
Other study ID # | 14/SS/0069 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 16, 2014 |
Est. completion date | September 2026 |
Patients with high blood pressure (hypertension) and chronic kidney disease are at an increased risk of developing heart disease and strokes. Part of this risk is due to changes in the structure and function of the blood vessels throughout the body. It is thought that reducing high blood pressure and treating chronic kidney disease improves the structure and function of blood vessels but information on this is limited. Optical coherence tomography (OCT) is a method of looking at the blood vessels at the back of the eye. It is a simple, quick and non-invasive test that you may have previously had during a visit to the optician. The purpose of the study is to ascertain whether OCT is able to detect changes in the eye's blood vessels in patients with hypertension and chronic kidney disease compared to healthy individuals and also to see if any differences seen improve with treatment.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 2026 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Male or female - Age 18-80 - Body mass index =35 - For those with hypertension: BP =140/90 or on treatment for hypertension - For those with CKD: CKD as defined by the Kidney Diseases Quality Initiative guidelines Exclusion Criteria: - Subject is below the age of legal consent, or is mentally or legally incapacitated - The subject has donated blood (450 ml) within the last 4 weeks - Past or present drug or alcohol abuse including intravenous drug abuse at any time - Participation in another clinical trial within 1 month - Considered to be at high risk of HIV or hepatitis B - Patients with known eye disease, or previous eye surgery, or refractive error greater than +/- 6 dioptres. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Edinburgh | Edinburgh | Midlothian |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Choroidal & retinal morphology | A composite measures outcome including:
Sub-foveal choroidal thickness Choroidal volume Retinal vasculature morphology and optimality measurements (arteriolar thickness, branching coefficient and branching angle; fractal dimension, and venular tortuosity.) |
2 weeks | |
Secondary | Neuro-retinal metrics | A composite measures outcome of neuro-retinal metrics (retinal thickness, retinal nerve fibre layer thickness) | 2 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
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