BMJ Open (Oct 2023)

Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of

  • Sobha Sivaprasad,
  • Clare Bailey,
  • Augusto Azuara-Blanco,
  • Mike Clarke,
  • Danny Mcauley,
  • Louise Downey,
  • Noemi Lois,
  • Norman Waugh,
  • Hema Mistry,
  • Victor Chong,
  • Faruque Ghanchi,
  • Ahmed Saad,
  • David H Steel,
  • Geeta Menon,
  • Haralabos Eleftheriadis,
  • Nachiketa Acharya,
  • Samia Fatum,
  • Tariq M Aslam,
  • Paul Doherty,
  • Sheena George,
  • Robin Hamilton,
  • Catherine Adams,
  • Clíona McDowell,
  • Markus Groppe,
  • James Stephen Talks,
  • Mandy Maredza,
  • Marianne Shiew,
  • Christina Campbell,
  • Evie Gardener,
  • Aby Joseph,
  • Matthew Mills

DOI
https://doi.org/10.1136/bmjopen-2022-067684
Journal volume & issue
Vol. 13, no. 10

Abstract

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Objectives To estimate the economic costs, health-related quality-of-life outcomes and cost-effectiveness of subthreshold micropulse laser (SML) versus standard laser (SL) for the treatment of diabetic macular oedema (DMO) with central retinal thickness (CRT) of <400µ.Design An economic evaluation was conducted within a pragmatic, multicentre, randomised clinical trial, DIAbetic Macular Oedema aNd Diode Subthreshold.Setting 18 UK Hospital Eye Services.Participants Adults with diabetes and centre involving DMO with CRT<400µ.Interventions Participants (n=266) were randomised 1:1 to receive SML or SL.Methods The base-case used an intention-to-treat approach conducted from a UK National Health Service (NHS) and personal social services (PSS) perspective. Costs (2019–2020 prices) were collected prospectively over the 2-year follow-up period. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained and the incremental net monetary benefit of SML in comparison to SL. Sensitivity analyses explored uncertainty and heterogeneity in cost-effectiveness estimates.Results One participant in the SL arm withdrew consent for data to be used; data from the remaining 265 participants were included in analyses. Mean (SE) NHS and PSS costs over 24 months were £735.09 (£111.85) in the SML arm vs £1099.70 (£195.40) in the SL arm (p=0.107). Mean (SE) QALY estimates were 1.493 (0.024) vs 1.485 (0.020), respectively (p=0.780), giving an insignificant difference of 0.008 QALYs. The probability SML is cost-effective at a threshold of £20 000 per QALY was 76%.Conclusions There were no statistically significant differences in EQ-5D-5L scores or costs between SML and SL. Given these findings and the fact that SML does not burn the retina, unlike SL and has equivalent efficacy to SL, it may be preferred for the treatment of people with DMO with CRT<400µ.Trial registration numbers ISRCTN17742985; NCT03690050.