Clinical confidence with an evidence-based approach: Q&A with Prof James Wolffsohn

An evidence-based approach to myopia management involves making clinical decisions and treatment recommendations based on high-quality scientific evidence and research findings¹ and integrating this with your own skillset and expertise, the unique clinical setting and the patient’s preferences and values.² This approach prioritizes treatments and interventions that have been proven through rigorous research to be safe and efficacious in reducing the rate of myopia progression, but also considers what is best for the individual patient and what is within an individual eyecare practitioner’s competency level to prescribe. It contrasts with approaches that rely solely on anecdotal evidence or tradition and emphasizes the importance of staying current with the latest scientific advancements in myopia management to provide the best possible care to patients.

The benefits of using an evidence-based approach to clinical myopia management are manifold: pertinent and current research means you are providing your patient with the most effective treatments to date; you can be sure your approach is safe and that long-term outcomes are predictable; furthermore, by focusing on interventions with a strong evidence base, unnecessary or ineffective treatments can be avoided, potentially reducing the financial burden on patients and healthcare systems.³ It also adds to your own professional credibility as it fosters trust between you and the patient when a treatment plan is efficacious: one happy myopic patient could bring a whole family into your practice because of the trust that has been built.

There are different types of studies published, and some carry more scientific strength than others. Systematic literature reviews and meta-analyses have the highest level of evidence as research methodologies, because they pool together evidence and data from multiple studies on a specific topic and are able to be comprehensive while having a low risk of bias.⁴ Obviously novel treatments are unable to have this level of evidence as there is not much existing literature on them to review yet: randomized controlled trials (RCTs) are able to provide strong evidence as they benefit from bias minimization through the process of masking and randomization.³ Other study designs such as cohort studies and case-control studies are also valuable where RCTs are unable to be performed due to ethical reasons, however they do have their limitations and tend to have more potential sources of bias.

There are a lot of things I look for when assessing any study. The study design, sample size, inclusion criteria, study duration (the IMI recommends a 2 year trial, as 6 months is too short due to the possible sessional effects), endpoints and outcomes, dropout rates and the reason behind it, and how the statistical evaluation is done are all important factors to consider. Another important aspect which can sometimes be undervalued is whether the research has been published: there’s a difference between unpublished data, data shared at conferences or congresses, and data that is published in a peer-reviewed journal. Specific to myopia research, factors such as participant age, ethnicity, and presence of parental myopia significantly impact RCT results and should be properly evaluated when assessing an RCT paper. The rebound effect is also an important point to review, and if an RCT provides this information it helps us predict clinical outcomes. 

Real-world data such as retrospective analyses, cohort and observational studies complement RCT data. Unlike randomized controlled trials (RCTs), which often have stringent exclusion criteria, real-world evidence allows us to assess treatment effects in the broader clinical landscape of an often more diverse and representative patient population. From this, we can better recommend interventions to the individual as we know where it may work better, when to stop and when to start. Similar to an RCT, I assess where the study is published, the quality and completeness of the data, how data was collected and validated, the sample size and the study design itself. 

If we look at the DIMS 6-year data that has just come out there are a lot of strong points: it involved 90 participants, and the study duration meant that it is the longest myopia management spectacle lens study to date.⁵ The RCT was successful in showing that the DIMS lens is a highly efficacious myopia management intervention. However, the RCT only involved ethnically Chinese children, but there is preliminary evidence for use in other ethnicities,⁶ as well as its use in combination with atropine is being further explored.⁷ So Hoya’s MiYOSMART has a strong evidence base for its use in myopia management.