• Quality of MIGS Trials

    By Jean Shaw
    Selected By: Henry D. Jampel, MD, MHS

    Journal Highlights

    Ophthalmology Glaucoma, March/April 2019

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    Mathew et al. assessed the quality of published studies of minimally invasive glaucoma surgery (MIGS) devices. They found that a substantial proportion of MIGS trials do not adhere to the World Glaucoma Association (WGA) guidelines, thus limiting comparison between trials and hindering meaning­ful evaluation of these technologies.

    For this study, the researchers searched five databases for comparative MIGS trials published from Jan. 1, 2000, to June 21, 2018. They then used the WGA guidelines—which cover the design, conduct, and reporting of glaucoma surgical trials—to evaluate the studies. Each study was assessed by two reviewers; differences were resolved by consensus.

    The researchers identified 25 studies that met all eligibility criteria; of these, 10 were randomized controlled trials (RCTs). Overall, the RCTs were more likely to comply with the WGA guide­lines than were the non-RCTs, with 52.8% of the RCTs complying, versus 40.8% of the non-RCTs. Problems with study design included the following:

    • The WGA guidelines recommend a follow-up on a defined schedule up to three years. Only four (16%) of the 25 studies lasted three years or more. Nearly half of the studies had a follow-up of 12 months; two lasted only six months.
    • With regard to intraocular pressure (IOP), the WGA guidelines consider two components mandatory for demonstrating surgical success: 1) an IOP-based survival curve with the number of patients at each time point and 2) an IOP scatterplot. None of the reviewed RCTs provided this infor­mation. Of the non-RCTs, two had a scatterplot, and seven included an IOP-based survival curve.
    • In 16 studies (64%), at least one author reported an association with the industry. Furthermore, at least one author was a shareholder in 32% of the studies, and 24% of studies had an industry employee as an author. The WGA guidelines suggest several tools that can be used to manage potential conflicts, including masked study design and funding from sources unrelated to the innovation.

    The researchers urged authors and journals to follow the WGA guidelines. As they pointed out, the development and use of standardized methodology and outcomes supports transparency of study results, facilitates comparisons between trials, and allows readers to accurately evaluate study results and assess new technologies such as MIGS.

    The original article can be found here.