Ideal MIGS trial: linking design to robust outcomes

Minimally invasive glaucoma surgery (MIGS) has seen widespread adoption over the past decade, yet considerable variation in clinical trial design and outcome reporting has resulted in substantial heterogeneity, complicating the interpretation of the available evidence. The MIGS Trial Design Task Force of the European Glaucoma Society has designed the ‘Ideal MIGS Trial Protocol’ in an effort to standardise the design and conduct of future randomised controlled trials (RCTs) evaluating the efficacy and safety of MIGS. This paper summarises the main principles of an exemplar protocol for RCTs: design (including the use of comparators, randomisation, masking and the adoption of target intraocular pressure and wash-out measurements), primary outcomes (incorporating assessment of disease progression), statistical analysis, trial monitoring and dissemination. The European Glaucoma Society strongly recommends this protocol forms the basis of all RCTs evaluating MIGS procedures. Clinical trials not following the suggested design are likely to be at high risk of biased estimates of treatment effects or of failing to capture important outcomes. Harmonisation of study design will facilitate meaningful trial comparisons and meta-analyses.