Diabetic Macular OedemaACE-OCTNCT07816627
Applied Conversion Equation for Optical Coherence Tomography
An observational study of Diabetic Macular Oedema, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The investigator wants to investigate how big the differences are between measurements of the back of the eye taken by different OCT machines. The study is called: Applied Conversion Equation for Optical Coherence Tomography (ACE-OCT) study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Oedema
- What is being tested?
- Optical coherence tomography scan
- How many people
- 338 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2024to 31 Oct 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of Diabetic Macular Oedema (DMO) as recorded on the Ophthalmology Electronic Medical Record system (Medisoft/Medisight) within Gloucestershire Hospitals NHS Foundation Trust.
Who may be able to join
- Patients aged 18 years or above
- Patients with a diagnosis of Type 1 or Type 2 Diabetes Mellitus
- Patients with a known diagnosis of DMO in at least one eye
- Patients being seen in DMO clinics, Digital Surveillance Clinic or Virtual Diabetic Retinopathy clinics
Who cannot join
- Patients under 18 years old
- People unwilling or unable to give informed consent
- Patients in whom it is not possible to take OCT scans, for instance those with:
- Dense cataracts
- Corneal Scarring
- Severe physical disabilities preventing them from adequate positioning.
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- People with other ocular pathologies known to impact retinal thickness, including:
- Age related Macular Degeneration (AMD)
- Branch or central retinal vein occlusion (BRVO/CRVO)
- Macular Hole
- Glaucoma
- High Myopia with a spherical equivalent > -5.00 diopters
- Epiretinal membrane
- Eyes with at least one scan containing segmentation errors
- Eyes with at least one scan that is ungradable
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, Gloucestershire, GL53 7AN
About this study
The investigator wants to investigate how big the differences are between measurements of the back of the eye taken by different OCT machines. The study is called: Applied Conversion Equation for Optical Coherence Tomography (ACE-OCT) study.
Read the detailed description
Optical Coherence Tomography (OCT) is a type of scan of the back of the eye. It is non-invasive and provides vital information about the health of the eye. It is commonly available in optometrists and hospital eye units. OCT scans are a mainstay for deciding if treatment is needed for Diabetic Macular Oedema (DMO). However, there are many different companies that make these OCT machines and there is variability between the measurements. The amount of variability is unknown. Clinically, this means that patients may be under or over treated unknowingly. From a research perspective, patients are being excluded from studies because measurements from OCT different machines cannot be compared accurately.
There is a need for a conversion equation so measurements between OCT machines can be compared. This would be of benefit for patients, for clinicians making treatment decisions and for researchers
This project addresses the knowledge gap of not knowing the amount of variability in measurements between OCT machines. By knowing this, diseases such as DMO may possibly be detected and treated earlier. It will also make it easier to track progression of disease if a patient moves to a different treatment centre or OCT machine. Crucially, it will help research as patients will not be excluded if participants were scanned on different OCT machines.
The key objective of this study is to collect OCT images for 338 patients (675 eyes) with DMO at the same time and place on the two different OCT machines (Heidelberg Spectralis and Topcon Triton). This will comprise of 450 eyes (225 patients) for the training of the model and a further 225 eyes to validate the model.
Firstly, this will help the investigator to quantify the variability in the measurements between the machines. Secondly it will help the investigator to build a conversion equation for measurements taken on Heidelberg Spectralis and Topcon Triton OCT machines. The final stage is to validate the conversion equation to ensure that the model is suitable to be used.
There may be patients whose disease is under or overestimated due to variability in measurements on the different OCT machines. This project would mean that patients with DMO are diagnosed more accurately and treated is a timelier way which would positively affect their visual outcome.
This project will help further sight-saving research. It would mean that patients are not excluded from studies purely because their OCT images are not comparable as they were taken on different machines. Having more eligible patients for research studies would improve the quality of research into existing and new treatments and better inform treatment guidelines
- Conditions
- Diabetic Macular Oedema
- Being tested
- Optical coherence tomography scan
- Keywords
- Optical Coherence Tomography, Diabetic Macular Oedema, Heidelberg Spectralis, Topcon Triton
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography scanDiagnostic test
Patients had OCT scans with both the Heidelberg Spectralis and Topcon Triton machines.
| Study group | Role | What they receive |
|---|---|---|
| Patients aged over 18 with a diagnosis of diabetes and diabetic macular oedema in at least one eye | Patients aged over 18 with a diagnosis of diabetes and diabetic macular oedema in at least one eye Receives: Diagnostic Test: Optical coherence tomography scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To calculate a conversion equation between two different OCT machines: Topcon Triton and Heidelberg Spectralis.
To calculate a conversion equation between two different OCT machines: Topcon Triton and Heidelberg Spectralis.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start3 Mar 2024
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular OedemaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 338 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter H Scanlon, Study chair, Gloucestershire Hospitals NHS Foundation TrustUshna Q Javed, Principal investigator, Gloucestershire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816627
- Sponsor's protocol ID
- 24/033/GHT
- Other IDs
- ML45437
- Acronym
- ACE-OCT
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethics we cannot share individual participant data, however we can share anonymised date on request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applied Conversion Equation for Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT07816627
- Acronym / sponsor ID
- ACE-OCT / 24/033/GHT
- Conditions
- Diabetic Macular Oedema
- Keywords
- Optical Coherence Tomography, Diabetic Macular Oedema, Heidelberg Spectralis, Topcon Triton
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 14 Sep 2026 (actual)
- 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.
The investigator wants to investigate how big the differences are between measurements of the back of the eye taken by different OCT machines. The study is called: Applied Conversion Equation for Optical Coherence Tomography (ACE-OCT) study.
Detailed description
Optical Coherence Tomography (OCT) is a type of scan of the back of the eye. It is non-invasive and provides vital information about the health of the eye. It is commonly available in optometrists and hospital eye units. OCT scans are a mainstay for deciding if treatment is needed for Diabetic Macular Oedema (DMO). However, there are many different companies that make these OCT machines and there is variability between the measurements. The amount of variability is unknown. Clinically, this means that patients may be under or over treated unknowingly. From a research perspective, patients are being excluded from studies because measurements from OCT different machines cannot be compared accurately.
There is a need for a conversion equation so measurements between OCT machines can be compared. This would be of benefit for patients, for clinicians making treatment decisions and for researchers
This project addresses the knowledge gap of not knowing the amount of variability in measurements between OCT machines. By knowing this, diseases such as DMO may possibly be detected and treated earlier. It will also make it easier to track progression of disease if a patient moves to a different treatment centre or OCT machine. Crucially, it will help research as patients will not be excluded if participants were scanned on different OCT machines.
The key objective of this study is to collect OCT images for 338 patients (675 eyes) with DMO at the same time and place on the two different OCT machines (Heidelberg Spectralis and Topcon Triton). This will comprise of 450 eyes (225 patients) for the training of the model and a further 225 eyes to validate the model.
Firstly, this will help the investigator to quantify the variability in the measurements between the machines. Secondly it will help the investigator to build a conversion equation for measurements taken on Heidelberg Spectralis and Topcon Triton OCT machines. The final stage is to validate the conversion equation to ensure that the model is suitable to be used.
There may be patients whose disease is under or overestimated due to variability in measurements on the different OCT machines. This project would mean that patients with DMO are diagnosed more accurately and treated is a timelier way which would positively affect their visual outcome.
This project will help further sight-saving research. It would mean that patients are not excluded from studies purely because their OCT images are not comparable as they were taken on different machines. Having more eligible patients for research studies would improve the quality of research into existing and new treatments and better inform treatment guidelines
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged over 18 with a diagnosis of diabetes and diabetic macular oedema in at least one eye | – | Diagnostic Test: Optical coherence tomography scanPatients aged over 18 with a diagnosis of diabetes and diabetic macular oedema in at least one eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of Diabetic Macular Oedema (DMO) as recorded on the Ophthalmology Electronic Medical Record system (Medisoft/Medisight) within Gloucestershire Hospitals NHS Foundation Trust.
Key inclusion criteria (4 listed)
- Patients aged 18 years or above
- Patients with a diagnosis of Type 1 or Type 2 Diabetes Mellitus
- Patients with a known diagnosis of DMO in at least one eye
- Patients being seen in DMO clinics, Digital Surveillance Clinic or Virtual Diabetic Retinopathy clinics
Key exclusion criteria (15 listed)
- Patients under 18 years old
- People unwilling or unable to give informed consent
- Patients in whom it is not possible to take OCT scans, for instance those with:
- People with other ocular pathologies known to impact retinal thickness, including:
- Eyes with at least one scan containing segmentation errors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherence tomography scanPatients had OCT scans with both the Heidelberg Spectralis and Topcon Triton machines. | Diagnostic test | Patients aged over 18 with a diagnosis of diabetes and diabetic macular oedema in at least one eye |
Primary outcome
To calculate a conversion equation between two different OCT machines: Topcon Triton and Heidelberg Spectralis.
Time frame: Through study completion, an average of 1 year
To calculate a conversion equation between two different OCT machines: Topcon Triton and Heidelberg Spectralis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. Due to ethics we cannot share individual participant data, however we can share anonymised date on request.
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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. This study is not recruiting at the moment.
Peter H Scanlon study chair
Gloucestershire Hospitals NHS Foundation Trust
Ushna Q Javed principal investigator
Gloucestershire Hospitals NHS Foundation Trust
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 Diabetic Macular Oedema, run by Gloucestershire Hospitals NHS Foundation Trust 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 4 inclusion and 15 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: finished, as of the sponsor's last update on 14 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To calculate a conversion equation between two different OCT machines: Topcon Triton and Heidelberg Spectralis. (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.