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NCT Number: NCT02132741

Optical Coherence Tomography And NEphropathy: The OCTANE Study

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.

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Key information

Conditions

Health Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cardiovascular Diseases Central Nervous System Diseases Chronic Disease Chronic Kidney Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genetic Diseases, X-Linked Hypertension Kidney Diseases Male Urogenital Diseases Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Ornithine Carbamoyltransferase Deficiency Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urea Cycle Disorders, Inborn Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Edinburgh

Edinburgh, Midlothian, EH164TJ, United Kingdom

Location status: Recruiting

Location contact

Neeraj Dhaun, MD PhD

PRINCIPAL_INVESTIGATOR

About this study

This project is an exploratory study, using enhanced depth imaging with the new SPECTRALIS OCT, designed to examine choroidal and microvascular retinal structure in patients with hypertension, chronic kidney disease (CKD), and in age and sex matched healthy controls. The study is non-invasive and takes only a few seconds to acquire these complex images. The Centre, where the images will be captured and where image analysis systems are located, is on the Royal Infirmary of Edinburgh (RIE) site close to the RIE outpatient clinics, making recruitment easy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Choroidal & retinal morphology

    Time frame: 2 weeks

    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.)

Secondary outcomes

  1. Neuro-retinal metrics

    Time frame: 2 weeks

    A composite measures outcome of neuro-retinal metrics (retinal thickness, retinal nerve fibre layer thickness)

Study contacts

Contact information is provided by the study sponsor or research team.

David Webb

CONTACT

[email protected]

01312429215

Neeraj Dhaun, MD PhD

CONTACT

[email protected]

01312429215

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

Assessment of Retinal Vasculature Using Optical Coherence Tomography in Health, Hypertension & Chronic Kidney Disease.

Important dates

Study start
2014
Primary completion
2027
Study completion
2028
First posted
May 7, 2014
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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