HealthNCT02132741
Optical Coherence Tomography And NEphropathy: The OCTANE Study
An observational study of Health and Hypertension, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Hypertension, Chronic Kidney Disease
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 May 2014to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Edinburgh
Edinburgh, Midlothian, EH164TJ
Neeraj Dhaun, MD PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Health, Hypertension, Chronic Kidney Disease
- Keywords
- OCT; hypertension; CKD
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic, Ornithine Carbamoyltransferase Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 2 weeks
Secondary outcomes (1)
Neuro-retinal metrics
A composite measures outcome of neuro-retinal metrics (retinal thickness, retinal nerve fibre layer thickness)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study start16 May 2014
- Primary completion31 Dec 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neeraj Dhaun, MD PhD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132741
- Sponsor's protocol ID
- 14/SS/0069
- Status last verified
- May 2026
- First submitted
- 29 Apr 2014
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27942587
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Retinal Vasculature Using Optical Coherence Tomography in Health, Hypertension & Chronic Kidney Disease.
- ClinicalTrials.gov ID
- NCT02132741
- Acronym / sponsor ID
- 14/SS/0069
- Conditions
- Health, Hypertension, Chronic Kidney Disease
- Keywords
- OCT; hypertension; CKD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 16 May 2014 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Choroidal & retinal morphology
Time frame: 2 weeks
A composite measures outcome including: 1. Sub-foveal choroidal thickness 2. Choroidal volume 3. Retinal vasculature morphology and optimality measurements (arteriolar thickness, branching coefficient and branching angle; fractal dimension, and venular tortuosity.)
1 secondary outcome
Neuro-retinal metrics
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Derived from this study: PubMed 27942587Balmforth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neeraj Dhaun, MD PhD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health and Hypertension, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neeraj Dhaun, MD PhD (01312429215, bean.dhaun@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choroidal & retinal morphology (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02132741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.