Introduction

The objectives of this report are to provide a review of the evidence available for myopia management interventions, identify gaps, and provide the basis for related guidance recommendations. This review is provided in the context of awaiting a new Cochrane review of the evidence in this area that will be updated continuously and supersede this document once available.

Contents

Summary

Myopia is increasing in prevalence, causing a global public health problem. By 2050, it is predicted that half the world’s population will have myopia, a known risk factor for sight threatening ocular pathology. Higher levels of myopia (>5D) are associated with a higher risk of these complications. Research has shown that myopia has a link to ocular health complications, even at lower levels of myopia (≤5D). The aim of myopia management (myopia control) is to delay the onset and slow the progression of myopia, thereby reducing the final level of myopia, which, in turn, is likely to help to maintain good ocular health later in life by reducing the associated risks. However, this needs to be considered in context with respect to absolute risk, as the incidence of these complications in the general population is low.

This review summarises the latest peer reviewed evidence relating to the effectiveness of myopia management for children at risk of myopia and for children with existing myopia.

There is evidence that delaying the onset of myopia helps limit the final level of myopia. Preventing or delaying onset is only currently possible through environmental adaptations to increase time spent outdoors and limiting indoor near vision activities.

There is evidence that optical treatments in the form of multifocal contact lens designs, orthokeratology lenses and myopia management spectacle lenses can be used to slow the dioptric progression of existing myopia. These three intervention strategies have similar levels of efficacy ranging from 40% to 60% reduction in the level of myopia progression over 1-3 years (which equates to a reduction of around 1D less myopia over 3-4 years)1 compared to standard optical correction modalities. Low dose atropine therapy also demonstrates similar reduction in myopia progression, but this is unlicensed in the UK and the availability of suitable dose products are limited. However, there is no evidence that these interventions prevent or delay myopia from starting to develop in the first place. 

While the association between the level of myopia and the risk of sight threatening pathology is well established, it will take many years to establish whether there is a direct link between slowing myopia progression and a reduced risk of sight loss due to the long-term nature of the studies required. This review has highlighted several gaps in the evidence that need to be addressed to fully understand the long-term benefits and risks associated with myopia management interventions.

Despite the limitations in the current evidence base, limiting the axial length of an individual’s eyes is likely to also reduce the choroidal thinning associated with greater axial lengths and level of myopia. This is likely to lead to a reduction in the risk of sight-threatening conditions, such as myopic maculopathy and retinal detachment, that are higher for myopes and which increase with each dioptre of myopia. 

Background and aims

Myopia is a global public health problem that is increasing in prevalence.1, 2, 3, 4, 5, 6 By 2050, it is predicted that half the world’s population will have myopia. Myopia not only results in blurred distance vision and dependence on refractive correction, but is a known risk factor for sight-threatening ocular pathology.3, 5 Higher levels of myopia are associated with an increased risk of ocular complications, including myopic maculopathy, glaucoma and retinal detachment5.

In the UK, evidence suggests that the prevalence of myopia in children aged between 10-16 years has more than doubled over the last 50 years, and children are becoming myopic at a younger age.7, 8 Children with myopic parents are more likely to be myopic than those without.7, 8 Furthermore, children who become myopic between the ages of 6-13 years tend to become more myopic than those in whom myopia develops at a later age.7, 9, 10, 11 The proportion of myopic children aged 12-13 years in a recent UK study was 16.4%, significantly greater than that reported for children aged 10–16 years in the 1960’s (7.2%, p = 0.01).7

Research has shown that myopia, even at low levels, has a link to ocular health complications later in life.6 The aim of myopia management is to prevent or delay onset, or once present, slow the progression of existing myopia. This in turn is likely to help maintain good ocular health later in life12. The majority of treatment interventions are based on inducing and/or manipulating optical defocus12. Other mechanisms of action include biochemical influence through application of pharmacological agents (low-dose atropine therapy)12, but these agents are not currently licensed in the UK. 

This review involved searches for systematic reviews, meta-analyses and individual randomised controlled trials on the clinical effectiveness of myopia management interventions in children with myopia. This was achieved using a standardised literature search methodology within peer-reviewed scientific journal databases – PubMed, Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica dataBASE (EMBASE), Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Reviews of Effects (DARE) and Centre for Reviews and Dissemination (CRD) Health Technology Assessment (HTA) CINAHL, Cochrane Library, Web of Science, Library and Information Science Abstracts (LISA), Scopus, the National Library of Medicine (NLM) and Google Scholar. A panel of subject matter experts (see appendix A)was asked to review the results of these searches and provide information about missing evidence (from published studies) and literature that was in press, up to March 2022. Papers were reviewed for relevance and the subject matter experts invited to review the research team’s decisions on whether to include or exclude papers.

This review was undertaken in the context of there being a completed Cochrane systematic review published in 2020 and a published protocol for a new living systematic review and networked meta-analysis of the evidence in this area from 2021. This evidence review will be superseded when the new living Cochrane review is available. 

By 2050

It is predicted that half the world’s population will have myopia

Children aged between 10-16 years

Prevalence has more than doubled over the last 50 years

Even at low myopia levels

There is a link to ocular health complications later in life

Evidence overview

Environmental optimisation

There is good evidence that shows that spending increased time outdoors is effective against the development of myopia, although the exact mechanism by which the protective factors are exerted remains unclear.12, 13, 14, 15, 16 There is also an association between increased “near work” activities (such as screen use) and myopia progression, although there is very limited evidence that reduced frequency of near work is effective against the development or progression of myopia14. This lifestyle advice may also offer benefits to children with existing myopia by slowing progression, but the evidence for this is not strong.12, 13, 14, 15, 16 

Treatment options for managing myopia

There are now a number of treatments or therapeutic interventions available for children once they become myopic. While various pharmacological agents have been investigated in clinical trials, some of which are in use elsewhere in the world, these are not currently licensed in the UK. The interventions that are currently available with specific marketing authorisation for myopia management in the UK include:

  • Myopia management contact lenses
  • Myopia management spectacle lenses.

The interventions available without specific authorisation for myopia management in the UK include:

  • Conventional multifocal contact lenses
  • Conventional orthokeratology (ortho-k) contact lenses.

These optical interventions are based on defocus-driven regulation of eye growth, although the specific mechanism remains unclear.12, 17, 18 Imposing defocus has been shown in animal models to significantly affect eye growth, where myopic defocus has been shown to slow elongation speed or inhibit eye growth. 12 17, 18.

Myopia management contact lenses

The number of soft and orthokeratology contact lenses used for myopia management available in the UK has increased and is likely to grow in coming years. There is evidence from randomised controlled trials that myopia management and conventional multifocal contact lenses of various designs can be used to slow the dioptric progression of myopia, with efficacy ranging from 40% to 60% reduction in spherical equivalent refractive error over 1-3 years compared to controls, although the majority of this effect occurred during the early phase of treatment.17, 18, 19, 20, 21 These studies also report reduction in axial elongation ranging from 30% to over 50% during the same period.  

Similar levels of efficacy have been found for orthokeratology lenses in several meta-analyses,22, 23 but systematic reviews suggest the treatment effects in both contact lens and ortho-k approaches may reduce over time.17, 24 One study examining the impact on ceasing orthokeratology lens wear have shown this may lead to subsequent increased rate of axial elongation, known as a “rebound effect”.25 

Standard single vision soft or rigid gas permeable lenses have been shown in randomised controlled trials to be ineffective at slowing myopia progression or axial elongation.26, 27 

A recent review of the evidence relating to the safety of myopia management interventions in children provides reassurance that contact lens wear, including orthokeratology, by children is generally safe.28 The incidence of corneal infiltrative events in children is no higher than in adults, and in the youngest age range of 8 to 11 years, it may be markedly lower.28, 29 Evidence from systematic reviews of the safety of orthokeratology suggests it is a safe option and has no significantly greater risk compared to other overnight contact lens modalities.30, 31 

This means the change from standard contact lenses to myopia management contact lenses or orthokeratology is unlikely to introduce any significant additional risk of corneal infections in children beyond that of any patient increasing their contact lens wearing times. Likewise, while there is an increased risk of corneal infections in children and young adults when moving from spectacle wear to myopia management contact lens wear, the risk is not significantly different compared to moving to conventional contact lens wear.28 The risk of corneal infection can be significantly reduced with proper instruction and advice on safe handling, maintenance and storage of these lenses and hand hygiene.29

Myopia management spectacle lenses

Specifically designed myopia management spectacles lenses have recently become available in the UK as a treatment option with specific marketing authorisation. Data from a 3-year follow-up study showed that spectacle lens designs incorporating peripheral myopic defocus slowed the progression of myopia and reduced axial elongation by approximately 50% and 60% respectively, although the majority of this effect occurred during the early phase of treatment.32

Clinical trials involving other spectacle lens designs within the current review period have not shown any benefit compared to standard single vision spectacle correction.33 Attempts using standard bifocals or progressive addition lenses to reduce accommodation during near work have been shown to provide a small but clinically insignificant benefit in slowing myopia progression.17 

While the safety of myopia management spectacle lenses has not yet been explicitly addressed in the literature, there is no evidence to suggest that myopia management spectacle lenses are harmful. This means that the change from standard spectacles to myopia management spectacles is not expected to introduce any significant additional risk.

Low dose atropine

The location and mechanism of action of atropine to slow myopia progression is not fully understood.11 However, in vitro studies on scleral and choroidal fibroblasts suggest that atropine increases thickness and rigidity of the scleral tissue while improving blood flow in the choroid, reducing the tendency toward axial elongation and myopia progression.34 A systematic review showed significantly less myopic progression with atropine compared to placebo and tropicamide across a range of doses.17 Low dose atropine for myopia management is not currently licensed in the UK but is likely become available in the future. A UK trial of low dose atropine to manage myopia is currently underway.35

All optical treatments 

There is evidence that multifocal contact lens designs, orthokeratology lenses and myopia management spectacles can be used to slow the dioptric progression of myopia. These three interventions strategies have similar levels of efficacy ranging from 40% to 60% reduction in the level of myopia for 1-3 years, compared to the progression observed with standard optical correction (controls). There are currently no published studies that have investigated whether these optical interventions prevent or delay myopia from developing.

The benefits of constraining the level of myopia are not limited to potentially reducing the risk of future ocular morbidity. Lower levels of myopia offer improved uncorrected and corrected visual acuity, reduced dependence on vision correction, improved spectacle wear cosmesis and comfort due to reduction in lens thickness and weight, and better outcomes following corneal refractive surgery.6, 12, 36, 37 There may be additional benefits of children wearing contact lenses, in terms of increasing engagement in sports activities and confidence with respect to social interactions and cosmesis.6, 36, 37

No economic evaluations were identified to determine the cost-effectiveness of myopia management treatments in children with myopia. However, a single study that modelled the risk-benefit of reducing the level of myopia showed that the number of patients needed to treat to prevent 5 years of visual impairment caused by myopia associated conditions is between 4.1 and 6.8.37 This means at least 5 people need to be treated in order to prevent 5 years of vision loss that significantly affects their quality of life.

Areas of uncertainty

Although the evidence base on the efficacy of myopia management has grown since The College of Optometrists myopia management guidance was first published, there are still important questions that remain. Key considerations relating to the current evidence include:

  • While there is evidence to help understand which children may be at more risk of developing myopia or progressing rapidly, we cannot yet accurately predict which (and to what extent) patients will benefit most from a given intervention or combination of interventions, or explain why variations in response to interventions occur.
  • Myopia prevalence studies to date have focused mainly on children living in Asian countries and of Asian ethnicities, although there is a growing body of evidence in children of a wider range of ethnicities living in European countries. It is known that myopia prevalence varies with geographic location and that there may be differences in the mechanisms underpinning myopic eye growth across ethnicities. Therefore, a successful intervention in one group might not have the same outcomes in another. This means we do not know whether the current evidence base relating to slowing progression would be fully relevant to children living in European countries. Further studies in European populations are underway, which should improve the evidence available for children of all ethnicities in the European population.
  • Evidence relating to longer term (>4 years) follow up of children undergoing myopia management intervention has recently become available38, whilst also offering valuable insights into the effects of ceasing treatment over a longer period. However, there are still too few studies of adequate duration to fully understand the rebound effect and the longer-term impact of interventions.  This means there is not currently enough evidence to determine when to stop treatment, or to fully assess the longer-term risks and benefits of myopia management.
  • Practitioners must be aware of any potential rebound effect, after cessation of treatment. The International Myopia Institute (IMI) recommends investigation of possible rebound effects for all interventions, and the minimum requirement for this is at least 12 months.35 As the research in this area evolves, we expect to see more published data regarding what happens when a particular intervention is ceased.
  • There is insufficient direct evidence that the available myopia management interventions reduce the future risk of sight-threatening ocular pathology associated with myopia in the long term, by limiting the degree of myopia or axial elongation. While population-based studies have shown that slowing myopia by 1 dioptre may reduce the relative risk of developing future ocular health complications by 40%36, this needs to be considered in context with respect to absolute risk, as the incidence of these complications in the general population is low. Research in this area is limited due to the dependence on the frequency of follow-up and considerable timescales as to when these pathologies are more likely to develop. However, ongoing studies will provide significant data spanning several years, as recommended by the IMI.
  • There are very few epidemiological studies available to determine key metrics such as the number (of patients) needed to treat (NNT[1]). It is therefore difficult to determine how much an individual’s risk of sight-threatening ocular pathology may be reduced. This also has implications for fully understanding the cost-effectiveness of myopia management, which is necessary for appraising funding viability, given that these interventions are not currently offered by national health services within any part of the UK.

The College supports the updated IMI guidelines for research that advocate for more studies with longer intervention periods, and longer follow up periods once the interventions have been discontinued.39 Such research is critical to our understanding of these interventions and to assessing the long-term benefits and outcomes of the interventions, as well as the possible risks and unintended consequences of their use.

a NNT indicates the number of patients who would need a specific treatment (such as myopia management) to prevent a single negative outcome (such as retinal detachment).

Conclusions

Despite the gaps in the evidence, limiting the axial length of an individual’s eyes is likely to reduce the choroidal thinning associated with greater axial lengths and level of myopia. This is also likely to lead to a reduction in the risk of sight threatening conditions such as myopic maculopathy and retinal detachments that are higher for myopes, and which increase with each dioptre of myopia. However, this relative reduction in risk needs to be considered in context with respect to absolute risk, as the incidence of these complications in the general population is low.

Research into the benefits of myopia management is ongoing and our knowledge of the longer-term benefits of myopia management will continue to grow. As more studies are completed, the overall reliability of evidence will increase, as will the capacity to combine data from multiple studies to produce larger meta-analyses.

References

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  10. Tricard, D., Marillet, S., Ingrand, P., Bullimore, M. A., Bourne, R. R., & Leveziel, N. (2022). Progression of myopia in children and teenagers: a nationwide longitudinal study. British Journal of Ophthalmology, 106(8), 1104-1109.
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  12. Németh, J., Tapasztó, B., Aclimandos, W. A., Kestelyn, P., Jonas, J. B., De Faber, J. T. H., ... & Resnikoff, S. (2021). Update and guidance on management of myopia. European Society of Ophthalmology in cooperation with International Myopia Institute. European Journal of Ophthalmology, 31(3), 853-883.
  13. Xiong, S., Sankaridurg, P., Naduvilath, T., Zang, J., Zou, H., Zhu, J., ... & Xu, X. (2017). Time spent in outdoor activities in relation to myopia prevention and control: a meta‐analysis and systematic review. Acta ophthalmologica, 95(6), 551-566.
  14. Foreman, J., Salim, A. T., Praveen, A., Fonseka, D., Ting, D. S. W., He, M. G., ... & Dirani, M. (2021). Association between digital smart device use and myopia: a systematic review and meta-analysis. The Lancet Digital Health, 3(12), e806-e818.
  15. Gajjar, S., & Ostrin, L. A. (2022). A systematic review of near work and myopia: measurement, relationships, mechanisms and clinical corollaries. Acta Ophthalmologica, 100(4), 376-387.
  16. Dhakal, R., Shah, R., Huntjens, B., Verkicharla, P. K., & Lawrenson, J. G. (2022). Time spent outdoors as an intervention for myopia prevention and control in children: an overview of systematic reviews. Ophthalmic and Physiological Optics, 42(3), 545-558.
  17. Walline, J. J., Lindsley, K. B., Vedula, S. S., Cotter, S. A., Mutti, D. O., Ng, S. M., & Twelker, J. D. (2020). Interventions to slow progression of myopia in children. Cochrane Database of Systematic Reviews, (1).
  18. Wildsoet, C. F., Chia, A., Cho, P., Guggenheim, J. A., Polling, J. R., Read, S., ... & Wolffsohn, J. S. (2019). IMI–interventions for controlling myopia onset and progression report. Investigative ophthalmology & visual science, 60(3), M106-M131.
  19. Walline, J. J., Walker, M. K., Mutti, D. O., Jones-Jordan, L. A., Sinnott, L. T., Giannoni, A. G., ... & BLINK Study Group. (2020). Effect of high add power, medium add power, or single-vision contact lenses on myopia progression in children: the BLINK randomized clinical trial. Jama, 324(6), 571-580.
  20. Chamberlain, P., Peixoto-de-Matos, S. C., Logan, N. S., Ngo, C., Jones, D., & Young, G. (2019). A 3-year randomized clinical trial of MiSight lenses for myopia control. Optometry and Vision Science, 96(8), 556-567.
  21. Ruiz-Pomeda, A., Pérez-Sánchez, B., Valls, I., Prieto-Garrido, F. L., Gutiérrez-Ortega, R., & Villa-Collar, C. (2018). MiSight Assessment Study Spain (MASS). A 2-year randomized clinical trial. Graefe's Archive for Clinical and Experimental Ophthalmology, 256(5), 1011-1021.
  22. Si, J. K., Tang, K., Bi, H. S., Guo, D. D., Guo, J. G., & Wang, X. R. (2015). Orthokeratology for myopia control: a meta-analysis. Optometry and Vision Science, 92(3), 252-257.
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  26. Walline, J. J., Jones, L. A., Mutti, D. O., & Zadnik, K. (2004). A Randomized Trial of the Effects of Rigid Contact Lenses on MyopiaProgression. Archives of ophthalmology, 122(12), 1760-1766.
  27. Katz, J., Schein, O. D., Levy, B., Cruiscullo, T., Saw, S. M., Rajan, U., ... & Chew, S. J. (2003). A randomized trial of rigid gas permeable contact lenses to reduce progression of children’s myopia. American journal of ophthalmology, 136(1), 82-90.
  28. Prousali, E., Haidich, A. B., Fontalis, A., Ziakas, N., Brazitikos, P., & Mataftsi, A. (2019). Efficacy and safety of interventions to control myopia progression in children: an overview of systematic reviews and meta-analyses. BMC ophthalmology, 19(1), 1-17.
  29. Bullimore, M. A. (2017). The safety of soft contact lenses in children. Optometry and Vision Science, 94(6), 638-646.
  30. Lipson, M. J., Brooks, M. M., & Koffler, B. H. (2018). The role of orthokeratology in myopia control: a review. Eye & contact lens, 44(4), 224-230.
  31. Liu, Y. M., & Xie, P. (2016). The safety of orthokeratology—a systematic review. Eye & contact lens, 42(1), 35-42.
  32. Lam, C. S., Tang, W. C., Lee, P. H., Zhang, H. Y., Qi, H., Hasegawa, K., & To, C. H. (2022). Myopia control effect of defocus incorporated multiple segments (DIMS) spectacle lens in Chinese children: results of a 3-year follow-up study. British Journal of Ophthalmology, 106(8), 1110-1114.
  33. Kanda, H., Oshika, T., Hiraoka, T., Hasebe, S., Ohno-Matsui, K., Ishiko, S., ... & Fujikado, T. (2018). Effect of spectacle lenses designed to reduce relative peripheral hyperopia on myopia progression in Japanese children: a 2-year multicenter randomized controlled trial. Japanese journal of ophthalmology, 62(5), 537-543.
  34. Cristaldi, M., Olivieri, M., Pezzino, S., Spampinato, G., Lupo, G., Anfuso, C. D., & Rusciano, D. (2020). Atropine differentially modulates ECM production by ocular fibroblasts, and its ocular surface toxicity is blunted by colostrum. Biomedicines, 8(4), 78-89.
  35. Azuara-Blanco A., Logan N., Strang N., Saunders K., Allen P.M., Weir R, Clarke M. (2020) Low-dose (0.01%) atropine eye-drops to reduce progression of myopia in children: a multicentre placebo-controlled randomised trial in the UK (CHAMP-UK)-study protocol. Br J Ophthalmol.104(7):950-955.
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  37. Bullimore, M. A., Ritchey, E. R., Shah, S., Leveziel, N., Bourne, R. R., & Flitcroft, D. I. (2021). The risks and benefits of myopia control. Ophthalmology, 128(11), 1561-1579.
  38. Chamberlain, P., Bradley, A., Arumugam, B., Hammond, D., McNally, J., Logan, N. S., ... & Young, G. (2022). Long-term effect of dual-focus contact lenses on myopia progression in children: a 6-year multicenter clinical trial. Optometry and Vision Science, 99(3), 204-212.
  39. Flitcroft, D. I., He, M., Jonas, J. B., Jong, M., Naidoo, K., Ohno-Matsui, K., ... & Yannuzzi, L. (2019). IMI–Defining and classifying myopia: a proposed set of standards for clinical and epidemiologic studies. Investigative ophthalmology & visual science, 60(3), M20-M30.

Appendix A

Myopia Management Expert Panel

Professor Bruce JW Evans
Director of Research
Institute of Optometry

Dr Hetal Buckhurst
Associate Professor in Optometry
University of Plymouth 

Professor Jeremy A. Guggenheim
Professor in Myopia Research
Cardiff University

Professor Kathryn J. Saunders
Professor of Optometry and Vision Science
Ulster University

Mr Max Halford
Clinical Lead
Association of British Dispensing Opticians (ABDO)

Professor Nicola S. Logan
Professor of Optometry & Physiological Optics
School of Optometry, Aston University, Birmingham, UK

Professor Peter Allen
Professor of Optometry and Visual Science
Anglia Ruskin University

Professor Chris Hammond
Frost Professor of Ophthalmology
King’s College London

Mr Indie Grewal 
Immediate-past President and Myopia Special Interest Group Lead
British Contact Lens Association (BCLA)

Professor John Lawrenson
Co-ordinating Editor
Cochrane Eyes and Vision Group

Dr Lesley Doyle
Lecturer in Optometry
Ulster University

Professor Niall Strang
Professor of Vision Sciences
Glasgow Caledonian University

Mr Paul Carroll
The Association for Eye Care Providers (FODO)

Dr Peter Hampson
Clinical & Professional Director
Association of Optometrists (AOP)

Published: August 2022

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