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DIAMONDS

  • Research type

    Research Study

  • Full title

    Diabetic Macular Oedema and Diode Subthreshold Micropulse Laser (DIAMONDS): A pragmatic, multicentre, allocation concealed, prospective, randomised, non-inferiority double-masked trial

  • IRAS ID

    207927

  • Contact name

    Noemi Lois

  • Contact email

    n.lois@qub.ac.uk

  • Sponsor organisation

    Belfast HSC Trust

  • Duration of Study in the UK

    4 years, 1 months, 31 days

  • Research summary

    DIAMONDS is a Randomised Clinical Trial that is being carried out in UK to determine the clinical effectiveness and cost-effectiveness of micropulse laser, compared with standard laser, for the treatment of diabetic macular oedema.

    Diabetic retinopathy is the damage of the retina caused by diabetes. People with diabetes and diabetic retinopathy may lose vision as a result of them developing what is called diabetic macular oedema (DMO). DMO is the most common complication of diabetes in the back of the eye. In DMO fluid leaks in the centre of the retina; the accumulation of the fluid reduces the vision, as the retina (the layer in the back of the eye responsible for our sight) needs to be dry to work properly. If the fluid is left untreated, permanent and irreversible visual loss will occur.

    The amount of fluid in the macula can be measured by doing a scan of the eye called optical coherence tomography (OCT). Depending on the amount of fluid present in the macula, people with DMO will be offered medicines known as anti-vascular endothelial growth factor (anti-VEGF) or laser treatment.

    The National Institute of Health and Care Excellence (NICE) found that laser treatment was effective in people with diabetic macular oedema and retinas that had been thickened by fluid but below to a certain limit (when the centre of the retina is less than 400 microns in thickness as measured by the OCT) and offers good value for money; better than anti-VEGF injections. Both, standard laser and micropulse laser, are being used currently in ophthalmic clinics across the world.

  • REC name

    HSC REC A

  • REC reference

    16/NI/0145

  • Date of REC Opinion

    17 Aug 2016

  • REC opinion

    Further Information Favourable Opinion