An observational study in Diabetic Macular Oedema, sponsored by Gloucestershire Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Gloucestershire Hospitals NHS Foundation Trust · Observational
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.
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
Gloucestershire Hospitals NHS Foundation Trust is the lead sponsor of 21 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients aged over 18 with a diagnosis of diabetes and diabetic macular oedema in at least one eye
Diagnostic Test: Optical coherence tomography scan
Patients had OCT scans with both the Heidelberg Spectralis and Topcon Triton machines.
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.
Time frame: Through study completion, an average of 1 year
Plan to share: No — Due to ethics we cannot share individual participant data, however we can share anonymised date on request.
No publications or documents are linked to this record.
Ran from Mar 2024 to primary completion in Oct 2025, 19 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Gloucestershire Hospitals NHS Foundation Trust