An open letter to The Ophthalmologist
David S. Hammond | | 4 min read | Opinion
With myopia prevalence rising and predicted to impact 50 percent of the global population in the coming decades, it is encouraging to see The Ophthalmologist (“Shutting Down Short-Sightedness,” May/June 2023) highlighting the importance of this evolving area of practice with insights from key European ophthalmologists, optometrists, and orthoptists.
Numerous myopia-controlling treatment strategies have been developed and tested including traditional spectacles (1), novel spectacle lens designs (2–4), soft contact lenses (5–7), corneal reshaping (orthokeratology) (8), and pharmaceuticals (9). The effectiveness and generalizability of myopia control treatments vary across clinical trials due to cohort variations, such as age, ethnicity, geographical location, and treatment compliance. Only one intervention (MiSight 1 day, soft contact lenses) has obtained US Food and Drug Administration (FDA) approval* for a myopia control indication, in addition to other approvals by regulatory bodies, such as China’s NMPA.* MiSight 1 day was also the first intervention with a CE regulatory indication to slow the progression of myopia in Europe – granted in 2009.
MiSight 1 day, a dual-focus, daily disposable soft contact lens, was highlighted in the article, but the discussion did not include the six years of extensive data supporting both efficacy and safety that have been published in peer review articles (5, 10).
The most valuable insights are gained from longer-term data. Following a three-year randomized controlled clinical trial, where all key factors known to influence myopia progression were well matched, treated eyes on average demonstrated significant slowing of myopia progression (59 percent, 0.73 D) and axial elongation (52 percent, 0.32 mm) (5). Similar slowed growth was observed over the extended six years of treatment, and in the originally untreated control eyes when switched to MiSight 1 day following three years of untreated growth (10). In the eyes switched from the single vision control contact lens to the MiSight 1 day treatment lens, it was possible to separate the effect of age from the treatment effect, which revealed that the treatment slowed eye growth by more than 50 percent (10).
Further analysis of the cohort fitted with MiSight 1 day lenses for six years of the study showed that 23 percent of eyes displayed a total refractive change of less than -0.25 D over six years and children wearing MiSight 1 day for six years progressed on average -0.92 D, compared with children in the single vision control group whom on average had progressed this amount by year two of the study. These outcomes demonstrate a robust myopia control effect in the majority of children.
The six years of clinical trial tracking enabled long-term ocular health assessments of children wearing daily disposable soft contact lenses. Results demonstrated an excellent safety profile with over 653 combined wearing years with no corneal infections and minimal impact on corneal physiology (11). This result supports the previous ReCSS study (12) that determined the real-world rate of microbial keratitis of 7.4/10,000 wearer years in soft contact lens wearers aged 8–16 years. Data from tertiary care, as reported in the feature, do not provide general data on the incidence of contact lens related adverse events nor do they provide the risk–benefit context of slowing myopia progression and the potential reduction in risk of myopia-associated pathology and vision impairment (13).
The Ophthalmologist’s commitment to addressing myopia prevention, progression, and treatment is important. CooperVision are also committed to transparently sharing our data and subsequent insights to ensure that myopic children can benefit from – and eye care providers can rely on – the strength of the evidence base that supports the use of MiSight 1 day as a clinically useful intervention. Ensuring that corresponding science is presented fairly and factually is critical to overcoming this global myopia epidemic.
*Availability and regulatory approval of MiSight 1 day varies by country.
- DA Goss, “Effect of spectacle correction on the progression of myopia in children--a literature review,” J Am Optom Assoc, 65,117 (1994)..
- CSY Lam et al., “Defocus incorporated multiple segments (DIMS) spectacle lenses slow myopia progression: A 2-year randomized clinical trial,” British Journal of Ophthalmology, 104, 363 (2020).
- J Bao et al., “Myopia control with spectacle lenses with aspherical lenslets: a 2-year randomized clinical trial,” Investigative Ophthalmology & Visual Science, 62, 2888 (2021).
- J Rappon et al., “CYPRESS 12-month Results: Safety and Efficacy from a Pivotal Study of Novel Spectacle Lenses Designed to Reduce Myopia Progression.” Presented at the American Academy of Optometry 2020.
- P Chamberlain et al., “A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control,” Optometry and Vision Science, 96, 556 (2019).
- JJ Walline et al., “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, 571 (2020).
- X Cheng et al., “Soft Contact Lenses with Positive Spherical Aberration for Myopia Control,” Optom Vis Sci, 93, 353 (2016).
- P Cho, Q Tan, “Myopia and orthokeratology for myopia control,” Clinical and Experimental Optometry, 102, 364 (2019).
- A Chia et al., “Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2 Myopia Control with Atropine 0.01% Eyedrops,” Ophthalmology, 123, 391 (2016).
- P Chamberlain et al., “Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial,” Optom Vis Sci, 99, 204 (2022).
- J Woods et al., “Ocular health of children wearing daily disposable contact lenses over a 6-year period,” Cont Lens Anterior Eye, 44 (2021). PMID: 33549474.
- RL Chalmers et al., “Adverse event rates in the retrospective cohort study of safety of paediatric soft contact lens wear: the ReCSS study,” Ophthalmic Physiol Opt, 41, 84 (2021).
- MA Bullimore et al., “The Risks and Benefits of Myopia Control,” Ophthalmology, 128, 1561 (2021).