Clinical trial offers more than a glimpse into eye treatments

A new clinical trial researching treatment for patients with sight loss as a result of diabetes has shown a type of laser treatment to be both cost effective and non-invasive, offering the best option for patients and healthcare providers.  

There are currently several treatment options offered to people with Diabetic Macular Oedema (DMO), including two types of laser treatment and eye injections. DMO is the most common sight-threatening complication of diabetes, affecting over 27 million adults. This new research provides much-needed evidence to enable patients and healthcare professionals to be better informed on treatment options. 

DMO happens when blood vessels in the retina at the back of the eye leak, causing fluid build-up at the macula, which provides central vision. The leakage occurs when high blood sugar levels damage blood vessels. 

The severity of DMO is most often determined by measuring the thickness of the macula, which in-turn will determine the treatment offered. Patients with more severe DMO (with thickness of 400 microns or more) are treated with injections into the eye of drugs, known as anti-VEGFs.

Patients with mild DMO (with thickness of less than 400 microns) can be treated with macular lase, which can be standard threshold laser or subthreshold micropulse laser. The former produces a burn or scar on the retina.  The latter, which is a more recent technology, works without leaving a burn or scar or any type of visible change or mark on the retina. 

The research,  published in Ophthalmology, found that subthreshold micropulse laser, which does not create a burn on the retina, was effective in maintaining a patient’s vision. This also requires much less frequent visits to the clinic and is much more cost effective than treatment via eye injections, with eye injections costing almost ten times more than laser treatments. 

Professor Noemi Lois, Clinical Professor of Ophthalmology at Queens University and Honorary Consultant Vitreoretinal Surgeon at the Belfast Health and Social Care Trust and lead author on the study, explains: “The absence of a scar or burn following subthreshold micropulse laser led to some healthcare professionals to doubt its effectiveness compared to the standard threshold laser.

“However, our research addressed this by demonstrating that subthreshold micropulse laser is as good as standard threshold laser for helping people’s vision, reducing macula thickness, allowing people to meet driving standards, and maintaining their quality of life, both in general terms and for vision in particular.” 

The research team set out to compare both types of available laser treatment through a large randomised clinical trial, known as DIAMONDS (DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser SML). They recruited 266 patients across 16 NHS hospitals around the UK, with half receiving standard threshold laser and the other half receiving subthreshold micropulse laser. Unique to this trial, patients were involved in selecting the outcomes, including how driving standards would be met following treatment. At the end of the two-year trial, DIAMONDS found both laser treatments to offer equivalent benefits. 

The total cost of the care of patients enrolled in the trial (including the laser treatment and any other treatments required as well as the costs of the follow-up visits) over two years was similar for both patient’s groups. Over the two-year period, the cost per patient was just under £900 (£897.83) for patients in the subthreshold micropulse laser arm of the trial compared to £1125.66 for those in the standard laser arm.  

Professor Lois adds: “Some ophthalmologists advise patients with milder forms of DMO to have injections of anti-VEGFs, rather than laser, despite laser being less invasive and requiring less visits to the clinic.

“Laser treatment costs significantly less than eye-injections of anti-VEGFs. With an average of ten injections required over two years, the total cost of eye injections per patient amounts to approximately £8,500 for the drug alone. This is almost ten times the cost of subthreshold micopulse laser without taking into account additional costings such as staff time. 

“Until we published these findings, there was no robust evidence comparing these types of laser treatments. A lack of information led some healthcare professionals to favour standard laser over subthreshold micropulse laser. We now have robust evidence to show that both laser treatments are not only effective in clearing the fluid from the retina and maintaining vision for at least two years, but both are also cost-effective.”  

“Armed with this knowledge, it’s likely that patients will opt for micropulse subthreshold laser, which doesn’t burn the retina and is comparable to standard laser. Whilst we didn’t directly compare laser treatments to treatment via eye injections of anti-VEGFs, hopefully we have shown that laser is an effective treatment, while remaining much less invasive to the patient and much less costly to the NHS.”  

The research was funded by the Health Technology Assessment (HTA) of the National Institute for Health and Care Research (NIHR). 

Clinical trial provides new approach for people with eye disease to increase NHS capacity

A UK-wide study, led by Queen’s University Belfast, has shown how a new surveillance pathway for people with stable diabetic eye disease is safe and cost-saving, freeing up ophthalmologists to evaluate and treat people requiring urgent care. 

The new health care surveillance pathway may help ophthalmic units across the world to improve their capacity whilst saving patient’s sight. It is already having a positive impact on the re-design of NHS services across the UK, having been implemented successfully in several hospitals. 

The research, funded by the National Institute for Health Research (NIHR), has been published in leading journals including Ophthalmology, BMJ and NIHR’s Health Technology Assessment. 

The EMERALD (the Effectiveness of Multimodal imaging for the Evaluation of Retinal oedemA and new VesseLs in Diabetic retinopathy) diagnostic accuracy study tested a new “ophthalmic grader” pathway. Rather than ophthalmologists, this pathway involves trained graders monitoring people with previously treated and stable complications of diabetic eye disease, namely diabetic macular oedema (DMO) and proliferative diabetic retinopathy (PDR), based on the reading of images and scans of the back of their eyes.  

The grader’s pathway can save £1390 per 100 patients, and the real savings are the ophthalmologist’s time, which can then be redirected to the evaluation of people at high risk of visual loss. 

Professor Noemi Lois, lead researcher and Clinical Professor of Ophthalmology from the Wellcome-Wolfson Institute for Experimental Medicine at Queen’s University Belfast, explains: “Diabetic macular oedema and proliferative diabetic retinopathy, the main sight-threatening complications of diabetic retinopathy can cause blindness if left untreated. It is therefore important to diagnose them and to treat them timely.

“NHS hospitals eye units are under significant pressure given the extremely high number of people that need to be examined and treated and given the insufficient number of ophthalmologists in the UK. Currently, ophthalmologists need to evaluate all patients, even those that are stable after treatment and who are doing well.” 

In EMERALD, trained ophthalmic graders were found to achieve satisfactory results when compared to standard care (i.e., ophthalmologists evaluating patients in clinic) while releasing ophthalmologist’s time. 

Professor Lois added: “EMERALD showed trained ophthalmic graders are able to determine whether patients with diabetic macular oedema or proliferative diabetic retinopathy previously successfully treated remain stable or if on them the disease has reactivated.  

“Thus, they would be able to follow people that have been already treated, releasing ophthalmologists’ time. Ophthalmologists could then use this time to treat timely other patients, for example, those who have indeed diabetic macular oedema or active proliferative diabetic retinopathy and who have not yet received treatment saving their sight.” 

Dr Clare Bailey, consultant ophthalmologist at the Bristol Eye Hospital, said: “The important data from the EMERALD study has helped us to significantly increase the numbers of people with diabetic retinopathy being seen in ‘imaging/grading’ pathways.

“This has hugely increased our follow-up capacity, whilst allowing ophthalmologists’ time to be directed to the people with diabetic retinopathy who need treatment or further assessment. 

“This has helped us to deal with the capacity pressures as a result of Covid -19 as well as the longer-term capacity demands due to the increasing prevalence of diabetic retinopathy.” 

Dr Caroline Styles, Consultant Ophthalmologist with NHS Fife, added: “Emerald provided us in NHS Fife with the relevant evidence that allowed us to redesign our pathways for people with diabetic eye disease.

“The involvement of people with diabetes in this study reassures our population that these are safe and appropriate changes, and not just based on cost.” 

The EMERALD study was set in 13 National Health Service (NHS) hospitals across the UK and is a large multicentric, UK-wide, National Institute for Health Research (NIHR)-funded diagnostic accuracy study.