BLOG: DIAMONDS: A MicroPulse trial focused on patient needs
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Key takeaways:
- A study investigated subthreshold MicroPulse laser therapy for center-involved diabetic macular edema.
- The treatment was a safe, effective and low-cost procedure.
Caesar Luo, MD, FACS, FASRS
Dr. Noemi Lois is my guest author today.
She brings extensive experience in diabetes as a clinical professor at Queen’s University in Belfast, Northern Ireland, where she leads a program of preclinical and clinical research focused on diabetic retinopathy and its complications. She recently served as the primary investigator for a clinical trial comparing the effectiveness and safety of subthreshold MicroPulse laser therapy (SML) and continuous-wave laser therapy (CWL) for center-involved diabetic macular edema.
Image: Adobe Stock
Noemi Lois, MD, PhD, FRCS(Ed), FRCOphth
One of SML’s greatest advantages has also sometimes led to skepticism about its effectiveness. Treatment with subthreshold MicroPulse laser does not cause a scar or burn. There are no structural changes observed following this treatment, even when looking at OCT and autofluorescence. This lack of tissue damage has led some health care professionals to doubt the efficacy of subthreshold MicroPulse compared with the standard threshold laser.
Several small randomized controlled trials had suggested that SML was as effective as CWL* for the treatment of DME, but there was a need for a larger, more robust trial. With this in mind, the United Kingdom’s National Institute for Health and Care Research commissioned and funded the Diabetic Macular Oedema and Diode Subthreshold Micropulse Laser (DIAMONDS) clinical trial, which was then conducted with the support of the Northern Ireland Clinical Trials Unit.
The trial was set within specialist hospital eye services at 16 sites in the United Kingdom. It evaluated the clinical effectiveness, safety and cost-effectiveness of SML therapy compared with CWL therapy for center-involved DME of less than 400 µm. Primary outcome was mean change in best corrected visual acuity in the study eye at 24 months.
Our team of investigators found SML has equivalent efficacy and cost to CWL. This result suggests that either treatment could be offered to patients with center-involved DME of less than 400 µm suitable for macular laser.
Listening to those living with diabetes and DME
The trial was designed with the needs of patients in mind. People living with diabetes and DME were involved in the study from the start because they are the only ones who can truly understand the way the condition affects a life. The patients discussed outcomes that were important to them as well as elements of study design that would make the process appealing for participants.
One outcome often mentioned as especially important was meeting driving standards. DIAMONDS found no statistically significant difference in the percentage of participants meeting driving standards following treatment with SML or CWL. The same was true for mean change in binocular BCVA, central retinal thickness, Humphrey visual field mean deviation, side effects and rescue treatments.
DIAMONDS showed SML treatment was safe, effective and a low-cost procedure. It is also a procedure that fits well with patients’ lifestyles, as they can resume activities directly after treatment. When DME is clearly present (ie, goes beyond subclinical cysts seen on OCT that do not represent DME) and signs of progression have been observed, there is a risk to sight, and I believe patients should be offered treatment with SML.
* In DIAMONDS, continuous-wave threshold laser therapy (CWL) is referred to as standard laser (SL).
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