Optical Coherence Tomography And NEphropathy: The OCTANE Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Chronic Kidney Disease; Health

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Neeraj Dhaun, MD PhD; Phone Number: 01312429215; Email: bean.dhaun@ed.ac.uk
• Study Contact Backup: Name: David Webb; Phone Number: 01312429215; Email: d.j.webb@ed.ac.uk

Study Locations

• United Kingdom
  • Midlothian
    • Edinburgh, Midlothian, United Kingdom, EH164TJ
      • Recruiting
      • University of Edinburgh
      • Principal Investigator: Neeraj Dhaun, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Healthy volunteers will be recruited from a research database. CKD and patients with hypertension will be recruited from these respective clinics in secondary care.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Treated hypertension; Patients on treatment for hypertension
CKD-ESRD; Pre- & post haemodialysis
Healthy individuals; Healthy volunteers
Chronic kidney disease; Pre-dialysis CKD & those with a functional renal transplant
Hypertension; Untreated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuro-retinal metrics	A composite measures outcome of neuro-retinal metrics (retinal thickness, retinal nerve fibre layer thickness)	2 weeks

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Investigators: Principal Investigator: Neeraj Dhaun, MD PhD, University of Edinburgh

Publications and helpful links

General Publications

• Balmforth C, van Bragt JJ, Ruijs T, Cameron JR, Kimmitt R, Moorhouse R, Czopek A, Hu MK, Gallacher PJ, Dear JW, Borooah S, MacIntyre IM, Pearson TM, Willox L, Talwar D, Tafflet M, Roubeix C, Sennlaub F, Chandran S, Dhillon B, Webb DJ, Dhaun N. Chorioretinal thinning in chronic kidney disease links to inflammation and endothelial dysfunction. JCI Insight. 2016 Dec 8;1(20):e89173. doi: 10.1172/jci.insight.89173.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2014
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: May 2, 2014
• First Posted (Estimated): May 7, 2014

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: OCT; hypertension; CKD
• Additional Relevant MeSH Terms: Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Renal Insufficiency; Genetic Diseases, X-Linked; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Amino Acid Metabolism, Inborn Errors; Urea Cycle Disorders, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hypertension; Renal Insufficiency, Chronic; Ornithine Carbamoyltransferase Deficiency Disease
• Other Study ID Numbers: 14/SS/0069