HOYA broke new ground with its MiYOSMART defocus myopia management spectacle lens, and the company is continuing this trend by educating eyecare professionals about the ideal time to introduce atropine as a combination therapy in higher risk patients.
Almost immediately after HOYA Vision Care disrupted the myopia management landscape in Australia with its MiYOSMART defocus spectacle lens, optometrists began wondering what impact they could have on more rapidly progressing patients if this spectacle lens was combined with atropine.
There was little data to support this approach at the time, but since MiYOSMART – and its Defocus Incorporated Multiple Segments (D.I.M.S.) Technology – became available in Australia and New Zealand in October 2020, HOYA has been working with global experts to build an evidence base and consensus on how practitioners can combine the spectacle lens with atropine.
Mr Ulli Hentschel, national training and development manager for HOYA Lens Australia, says MiYOSMART has been a welcome addition to the expanding suite of myopia management treatments now available in Australia, acting as a gateway for many practitioners who began offering a proven intervention for the first time. Others have found this spectacle lens particularly useful for younger and/or newly diagnosed patients, as well as those wanting to avoid contact lenses.
In May 2022, eyecare professionals gained even greater confidence in the lens when six-year data was presented showing MiYOSMART’s myopia control effect was sustained over time.1 It marked the longest study on a myopia management spectacle lens and also reported a favourable outcome when measuring for rebound effect. This study built on the original two-year, double-blind randomised controlled trial, published in the British Journal of Ophthalmology, that concluded children aged 8-13 years wearing MiYOSMART had on average 60% less progression compared with single-vision wearers as measured by the axial elongation, and a 59% reduction in spherical equivalent refraction.2
With the lens establishing itself in markets across the globe, Hentschel says it made sense for HOYA to facilitate a discussion around combination treatment with atropine.
“When we first launched MiYOSMART, every other week there would be an inquiry about whether it could be combined with atropine, but there was limited evidence to go by at the time,” he explains.
“That’s the reason behind HOYA setting up an advisory meeting in 2022 and developing a consensus document that we can provide to eyecare professionals without them having to go through the literature themselves to arrive at a conclusion about how and when they could combine atropine with MiYOSMART.”
He’s referring to a landmark virtual advisory meeting last November when five well-known experts in paediatric myopia discussed their opinions on combination treatment with atropine and optical inventions. The advisory group comprised key experts from Europe and Asia, including Professor Hakan Kaymak from the Internationale Innovative Ophthalmochirurgie in Duesseldorf, Germany, who shared insights based on their clinical experience and research.
They discussed their experience with MiYOSMART, including clinical application of the lens in combination with 0.01% atropine drops in European myopic children and adolescents when the expected goal using the spectacle lens alone was not achieved. They noted “a better control effect” with the combination treatment and, importantly, reported no significant changes in visual acuity or binocular vision between the use of MiYOSMART spectacle lenses alone or in combination with low dosage atropine.
A key outcome of the advisory meeting was the group reaching consensus on combining MiYOSMART with atropine, helping practitioners make informed decisions about their myopia management.
Key findings
According to Hentschel, the consensus document helps practitioners distinguish whether patients can continue being prescribed monotherapy (MiYOSMART), or if they’d get greater benefit by combining the lens with atropine.
“This is largely centred on whether patients are achieving their treatment goal: is their myopia progressing at a normal rate based on emmetropic eye growth, in which case they are recommended to continue with MiYOSMART monotherapy,” he explains.
“Or if the patient is not achieving that, it’s about educating eyecare professionals about the additive effect of introducing atropine for a combination treatment – both interventions are using different mechanisms of action to reduce myopia progression, they’re complementary.”
Much of the consensus document is underpinned by whether patients are meeting their treatment goals. The five experts, led by Kaymak, noted that the idea of using emmetropic/physiological eye growth as a target for axial length progression has been described in several papers but was yet to be widely established.
However, they said increases of 0.1 mm/year have been shown to be associated with normal eye growth3, while a progression of more than 0.2 mm/year indicates the achievement goal hasn’t been met. It’s important to note normal eye growth is age dependent, with one Dutch study showing an average of 0.09 mm in 10–13-year-old emmetropes but 0.19 mm in 6-9-year-old emmetropes.4 But treatment targets can also vary by region.
“The goal of treatment is different between Asian and Caucasian children. Success in Asian children is considered to be an annual progression of refraction less than -0.80 D. In Caucasian children, European advisors recommend a threshold of -0.50 D or less progression per year,” the experts summarised.
When it comes to initiating treatment, the expert advisory panel recommended that older children with less risks of high myopia should start with optical options only. If the child is young and has high risk profile with myopia progression of >-0.50D in the previous six months, then combination treatment can be initiated immediately.
But what concentration of atropine is appropriate? The experts said they usually adapted the dosage individually depending on myopia control and side effects.
They referred to the LAMP study in Chinese children, in which dosages of 0.01%, 0.025%, and 0.05% were studied over a three-year period. A dose-dependent myopia control effect was observed, meaning the higher the dosage, the better the myopia control. While the side effects with 0.05% dosage was well tolerated in Asian children, the same was not reported in Caucasian children who have light coloured eyes.
“The experts see no significant changes in visual acuity or binocular vision between MiYOSMART spectacle lens alone or in combination with low dosage atropine,” the consensus document said.
“Contrast sensitivity was measured with MiYOSMART spectacle lens alone and in combination with atropine 0.01%, no difference was found.5 If the expected treatment goal is not achieved only with MiYOSMART spectacle lens, the experts noted a better control effect in combination treatment.”
Another important consideration is the regional variance between how practitioners prescribe atropine.
Currently, in Asia 0.01% to 0.5% atropine is prescribed to children, but this depends on the country and individual prescriber preferences. In some countries health insurance reimbursement has an influence such as in Taiwan where only concentrations of 0.125% and higher are covered and are therefore prescribed more often compared to lower dosages.
In many European countries, atropine is not reimbursed by health insurances and the most common dosage is still 0.01%, but, according to the consensus document, ophthalmological societies now tend to recommend the higher dosage of 0.02% to 0.05%.
What the studies say
Alongside the consensus document, the literature is beginning to build around combination spectacle lens and atropine treatment.
In October 2022, Kaymak published his own study assessing the safety of combining MiYOSMART with atropine 0.01%.5 In a small trial involving 12 young adults, he investigated combination therapy in terms of traffic safety. Each person recruited was evaluated for corrected distance visual acuity (CDVA), contrast sensitivity and glare sensitivity under the influence of DIMS spectacle correction alone and combination therapy with 0.01% atropine.
“DIMS glasses do not represent any risk to road safety. The safety-relevant visual functions are not adversely changed, even in combination therapy with atropine,” he concluded.
In an even more recent study led by Zhu Huang et al at Zhejiang University in Hangzhou, China, and published in December 2022, the research team looked at the treatment effects of DIMS spectacle lenses and 0.01% atropine. To their knowledge, this study was the first to evaluate the additive effects of DIMS spectacles and 0.01% atropine on slowing axial elongation in children with myopia.6
The retrospective study of 107 children aimed to determine whether the combined approach could slow myopia progression compared with DIMS spectacle lenses or single vision (SV) spectacle lenses alone.
“After a one-year follow-up, myopia progression and axial elongation were lower in participants receiving a combination of 0.01% atropine and DIMS spectacles than in those receiving DIMS spectacles alone and SV spectacles alone, indicating an additive effect in the combined treatment,” the authors reported.
“In this study, axial elongation over one year was dramatically slowed by 0.13 mm in participants treated with a combination of 0.01% atropine and DIMS spectacles compared with DIMS spectacles alone.”
Lifting standards
With the emergence of new research and a consensus on combination therapy, Hentschel says HOYA is aiming to remain at the forefront of myopia management , ensuring practitioners can make clear, informed decisions about providing evidence-based care.
It forms part of a broader effort to lift myopia management standards globally, which includes HOYA’s partnership with Haag-Streit and Device Technologies to provide a pathway towards optical biometer ownership (Lenstar Myopia).
“Since announcing this in October 2021, we’ve been pleased with the uptake of this program. As more optometrists open practices or look to elevate their myopia management offering, they are realising that optical biometry is where they need to be in order to provide that gold standard level of myopia management,” he says.
“Being able to provide objective measurements such as axial length ties back to the consensus document, and knowing whether patients are reaching their treatment goals with MiYOSMART alone, or whether atropine might need to be added to the equation.”
More reading
Is two better than one? Combining treatments for myopia control
A myopia first: Hoya lens shows long-term efficacy
Covering all bases of myopia management
References
1.Lam CSY, Tang WC, Zhang A, Tse D, To CH. Myopia control in children wearing DIMS spectacle lens: 6 years results. ARVO 2022 Annual Meeting, May 1-4, Denver, US.
2. Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomized clinical trial. British Journal of Ophthalmology. Published Online First: 29 May 2019. doi: 10.1136/bjophthalmol-2018-313739
3. Gifford KL, et al. IMI – Clinical Management Guidelines Report. Invest Ophthalmol Vis Sci. 2019;60(3):M184-M203.
4. Rationale for Intervention. MYOPIE.NL. Available from: https://www.myopie.nl/en/professionals/rationale-for-intervention/
5. Mattern A.-I., Kaymak H., Verkehrssicherheit von DIMS Brillengläsern und Atropin in der Kombinationstherapie zur Hemmung der Myopieprogression, DOG 2022 poster PDo11-01, https://dog-kongress.de/programm/poster-sessions/ (accessed: 5.10.2022)
6. Huang, Z., Chen, XF., He, T. et al. Synergistic effects of defocus-incorporated multiple segments and atropine in slowing the progression of myopia. Sci Rep 12, 22311 (2022). https://doi.org/10.1038/s41598-022-25599-z
