Clinical trial offers the best treatment option for patients with sight loss as a result of diabetes

A new clinical study exploring the treatment of patients with vision loss due to diabetes has shown that one type of laser treatment is both inexpensive and non-invasive, offering the best option for patients and healthcare providers.

Several treatment options are currently offered to people with diabetic macular edema (DMO), including two types of laser treatment and eye injections. DMO is the most common vision-threatening complication of diabetes, affecting over 27 million adults. This new research provides much-needed evidence so patients and healthcare professionals can be better informed about treatment options.

DMO occurs when blood vessels in the retina at the back of the eye leak, leading to a buildup of fluid at the macula that allows for central vision. 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 determines the treatment offered. Patients with more severe DMO (400 microns thick or more) are treated with injections into the eye of drugs known as anti-VEGFs. Patients with mild DMO (less than 400 microns thick) can be treated with maculase, which can be a standard threshold laser or a low-threshold micropulse laser. The former creates a burn or scar on the retina. The latter, a newer technology, works without leaving a burn or scar or any type of visible change or mark on the retina.

The NIHR-funded study, published in Ophthalmology, found that a subliminal micropulse laser that does not burn the retina is effective in maintaining a patient’s vision. This also requires far fewer frequent visits to the clinic and is much less expensive than eye injection treatment, with eye injections costing almost ten times more than laser treatments.

The lack of scar or burn after the subthreshold micropulse laser caused some healthcare professionals to doubt its effectiveness compared to the standard threshold laser.

However, our research addressed this issue by showing that the subthreshold micropulse laser is just as good as the standard threshold laser in improving people’s vision, reducing macular thickness, enabling people to meet driving standards and improving their quality of life to obtain, both general and for the eyesight special.”

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 of the study

The research team set out to compare both types of available laser treatment through a large randomized clinical trial known as DIAMONDS (DIAbetic Macular Edema and Diode Subthreshold micropulse laser SML). They recruited 266 patients in 16 NHS hospitals across the UK, half of whom received a standard threshold laser and half a lower threshold micropulse laser. Unique to this study, patients were involved in selecting outcomes, including how driving standards would be met after treatment. At the end of the two-year study, DIAMONDS determined that both laser treatments provided equivalent benefits.

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The total two-year cost of care for the patients enrolled in the study (including laser treatment and any other necessary treatments, as well as the cost of follow-up visits) was similar for both patient 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 study compared to £1125.66 for patients in the standard laser arm.

Professor Lois adds: “Some ophthalmologists recommend injections of anti-VEGFs instead of laser for patients with milder forms of DMO, although laser is less invasive and requires fewer visits to the clinic. Laser treatment costs significantly less than injections of anti-ocular VEGFs. With an average of ten injections required over two years, the total cost of eye injections per patient is around £8,500 for the drug alone. This is nearly 10 times the cost of a subliminal micropulse laser, with no additional costs such as staff time.

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

“Armed with this knowledge, patients are likely to choose a micropulse, subthreshold laser that does not burn the retina and is comparable to a standard laser. While we have not directly compared laser treatments to treatment through eye injections of anti-VEGFs, hopefully we have shown that laser is an effective treatment while remaining much less invasive for the patient and much less costly to the NHS.”

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