Clinical confidence with an evidence-based approach: Q&A with Prof James Wolffsohn
In this article:
Professor James Wolffsohn, a Professor of Optometry, discusses the evidence-based approach and how to apply it to clinical practice.
- What does an evidence-based approach to myopia management mean?
- What are the benefits to clinical myopia management using an evidence-based approach?
- What are the different types of evidence?
- How do you evaluate evidence and assess whether it’s robust?
- Can you give an example of an intervention and an assessment of the evidence base?
Professor James Wolffsohn, a Professor of Optometry at Aston University since 2000, holds leadership roles as the Head of the School of Optometry and Head of the Department of Audiology. With an extensive background, including a PhD from Cardiff University, his research focuses on ophthalmic instrumentation, myopia management, and contact lenses. He is the Chief Scientific Officer of the International Myopia Institute and is instrumental in their White Paper Reports. We talk to him about how an evidence-based approach to myopia management is crucial in clinical practice.
What does an evidence-based approach to myopia management mean?
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.
What are the benefits to clinical myopia management using an evidence-based approach?
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.
What are the different types of evidence?
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.
How do you evaluate evidence and assess whether it’s robust?
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.
Can you give an example of an intervention and an assessment of the evidence base?
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.
PRODUCT DISCLAIMER – MiYOSMART has not been approved for myopia management in all countries, including the U.S., and is not currently available for sale in all countries, including the U.S.
Meet the Authors:
About James Wolffsohn
James S Wolffsohn is a National Teaching Fellow, and has published over 320 peer-reviewed papers and actively contributed to the British Contact Lens Association and TFOS DEWS II/Lifestyle Reports, where he served as a harmonizer and sub-committee chair. As the Chief Scientific Officer of the International Myopia Institute and joint-Chair of their white papers, he stands as a prominent figure in myopia research.
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Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ. 1996 Jan 13;312(7023):71-2. doi: 10.1136/bmj.312.7023.71.
Wolffsohn JS, Dumbleton K, Huntjens B, Kandel H, Koh S, Kunnen CME, Nagra M, Pult H, Sulley AL, Vianya-Estopa M, Walsh K, Wong S, Stapleton F. CLEAR - Evidence-based contact lens practice. Cont Lens Anterior Eye. 2021 Apr;44(2):368-397.
Wolffsohn JS, Whayeb Y, Logan NS, Weng R; International Myopia Institute Ambassador Group*. IMI-Global Trends in Myopia Management Attitudes and Strategies in Clinical Practice-2022 Update. Invest Ophthalmol Vis Sci. 2023 May 1;64(6):6.
Morais, F. B., Arantes, T. E. F. e ., Melo, G. B., & Muccioli, C. Levels of Evidence: What Should Ophthalmologists Know?. Revista Brasileira De Oftalmologia. 2019. 78(6), 413–417.
Lam CSY, Tang WC, Zhang HY, Lee PH, Tse DYY, Qi H, Vlasak N, To CH. Long-term myopia control effect and safety in children wearing DIMS spectacle lenses for 6 years. Sci Rep. 2023 Apr 4;13(1):5475.
McCullough S, Barr H, Fulton J, Logan NS, Nagra M, Pardhan S et al. 2-Year Multi-Site Observational Study of MiYOSMART myopia control spectacle lenses in UK children: 1-year results. Invest. Ophthalmol. Vis. Sci. 2023;64(8):4945. Parts of these data were presented as a poster at the Annual Research in Vision and Ophthalmology meeting, 2023.
Nucci P, Lembo A, Schiavetti I, Shah R, Edgar DF, Evans BJW. A comparison of myopia control in European children and adolescents with defocus incorporated multiple segments (DIMS) spectacles, atropine, and combined DIMS/atropine. PLoS One. 2023 Feb 16;18(2):e0281816.
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