MiyoSmart: The Partnership that Inspired a Spectacle Lens RevolutionWRITER Ulli Hentschel Having completed the longest running clinical study of myopia spectacle lenses, Hoya has demonstrated that long-term use of MiyoSmart Defocus Incorporated Multiple Segments (DIMS) spectacle lenses is an effective, safe, and non-invasive form of myopia management for children. In this article, Ulli Hentschel delves into the development of this innovative spectacle lens design and reviews the clinical studies, from the initial two-year randomised controlled clinical trial (RCT) through to the six-year follow-up study. He also discusses the goal of treatment and how relative peripheral refraction (RPR) may influence myopia control effect. LEARNING OBJECTIVES On completion of this CPD activity, participants should be able to: 1. Understand how MiyoSmart (DIMS) spectacle lenses were conceived. 2. Understand the clinical effectiveness from the two-, three- and six-year follow-up studies. 3. Realise that emmetropic eye growth should be considered as the treatment goal and that RPR may influence the myopia control effect of a treatment. We have allread inspiring stories of sudden ‘aha’ moments and overnight product successes. Physicist Paul Lauterbur claimed to have drafted his design for the magnetic resonance imaging (MRI) scanner on napkins at a Pittsburgh hamburger joint in 1971. Three decades later, his work won him a Nobel Prize. 1HP and its Silicon Valley start-up garage is another familiar story of invention, and more recently, disruptive technologies like Tesla, Uber and Airbnb have grabbed global headlines with innovations that have changed the world. In reality, these perceived overnight success stories required years of dedication to prove theories, bring ideas to fruition and resolve inevitable challenges. Hoya Vision Care’s MiyoSmart spectacle lens, developed in partnership with The Hong Kong Polytechnic University (PolyU) is no different. The lens has been highly successful and, since its launch in 2018, has become available in 28 markets with over two million spectacle lenses purchased by parents around the world.2Clinical evidence conducted by the Centre for Myopia Research at PolyU shows that it could slow myopia, on average by 60%, in a two-year randomised controlled clinical trial. This study was published in the British Journal of Ophthalmology.3This optical lens revolution had its own trials and tribulations during its ideation and development. THE EARLY DAYS OF DEVELOPMENTA high prevalence of myopia among the children of Hong Kong was first recognised in the early 1990s. By 1997, the Centre for Myopia Research had been formed, and funding secured from the Hong Kong government to conduct research to address this growing problem. A clinic was established at PolyU with the idea to create a contact lens to address myopia, but its development was not so easy. The PolyU team (Professor Chi-ho To and Professor Carly Lam) came up with a concept for a bi-focal lens with a ring structure that they believed would suppress myopia. They approached global suppliers with a request to partner in its manufacture. Met with refusal, they found a local supplier, had the prototype made, and began testing the technology. From 2000 to 2006 they tested the contact lens on chickens, then guinea pigs and later monkeys. The results were the same for all three groups – their contact lens had significant suppression rates in nearly 50% of the cases. A human clinical trial from 2007 to 2010 showed that the contact lenses slowed the progression of myopia by 25%. The myopia control effect reached 60% in children who wore the lenses for eight or more hours daily. In 2002, Prof To presented on myopia research at a public education seminar at a Hong Kong Science Museum event. His talk garnered the interest and support of more than 200 attending parents who were desperate to find answers to the growing myopia problem in children. Their desire to help their children fuelled his passion. HOYA VISION CARE PARTNERSHIPIn 2011, with a patent in place, PolyU approached Hoya to determine the company’s level of interest in working together on contact lenses to slow the progression of myopia in children. The Hoya Vision Care team initially agreed, however, after further exploration, they found the myopia control contact lens to be less than ideal for children. Instead, HOYA proposed a clinical trial using special spectacle lenses. Interestingly, the pivot for PolyU was not significant. In fact, Professor To had already envisioned the concept of a spectacle lens that would address the problem of myopia in children. The team concluded that optical defocus spectacle lens, based on the concept of the defocus incorporated soft contact (DISC) lens, was likely to have the same degree of effect as contact lenses. GIVING SHAPE TO THE IDEAIn developing their concept, Hoya and PolyU wanted to create a product that was easy to prescribe and had the aesthetically appealing look of a regular lens. They envisioned a unique micro lens in a honeycomb structure. One section would have a corrective optical power suited to the individual user. A second section would be out of focus, to create a myopic defocus (an optical plus power to slow myopia progression). With collaborative research into lens materials and the manufacturing process, they identified the optimal combination for clear vision and myopia control effect (Figure 1).Figure 1. The design of the Defocus Incorporated Multiple Segments (DIMS) spectacle lens. Figures 2. Schoolchildren wearing DIMS spectacle lenses had myopia progression significantly reduced by 59% (mean difference −0.55±0.09 D, p<0.0001). Axial elongation slowed down by 60% (mean difference 0.32±0.04 mm, p<0.0001) compared with those wearing single vision spectacle lenses.3Figure 3A. Percentage of the subjects with and without myopia progression at the 24-month visit. MP=myopia progression, MR = myopia reduction. Figure 3B. Percentage of the subjects with and without axial elongation at the 24-month visit.The first prototype of their ‘Defocus Incorporated Multiple Segments’ (DIMS) spectacle lens was completed at the end of 2012 and, after making several improvements, a clinical trial, involving 183 children commenced in 2014. The results of the two-year clinical trial, conducted by the Centre for Myopia research at PolyU, compared the effect of the innovative DIMS spectacle lens against single vision spectacle lenses. It showed that the DIMS spectacle lens slowed down the progression of myopia by 60%, on average, for all participants who completed the study.3The results far surpassed initial predictions. The long-term effects continued to be studied with data from a three-year follow-up study published in British Journal of Ophthalmologyin 2021, 4and a six-year follow-up study presented by Prof Lam at the Association for Research in Vision and Ophthalmology (ARVO) conference in May 2022. 5With evidence of its effectiveness, the MiyoSmart DIMS spectacle lens was launched to selected markets in July 2018 and was released in Australia and New Zealand in October 2020. The MiyoSmart DIMS spectacle lens has won several awards and is the first ophthalmic lens for myopia control with such high efficacy rates and strong evidence over a six-year period. However, MiyoSmart was certainly no overnight success, proving the value of persistence, determination, and strong partnerships committed to combating the growing problem of myopia in children. CLINICAL EVIDENCE Two-Year Randomised Controlled Clinical Trial (RCT) The two-year RCT showed incredibly promising results, with on average 59% slowdown of spherical equivalent of refraction (SER), and a 60% slowdown of axial length (AL) across the whole cohort (Figure 2). “ In developing their concept, Hoya and PolyU wanted to create a product that was easy to prescribe and had the aesthetically appealing look of a regular lens Seventeen (21.5%) out of 79 children wearing DIMS spectacle lenses had no myopia progression over two years (Figure 3a), which was higher than the single vision group (six of 81, 7%). Likewise, 14% of the children wearing DIMS spectacle lenses had no axial elongation, whereas all children in the single vision group had axial elongation (Figure 3b). Three-Year Follow-Up Clinical Study In March of 2021 the 3-year follow-up clinical study results were published in British Journal of Ophthalmology. This study was conducted on 120 children in Asia. It included 65 from the group using the MiyoSmart spectacle lens in the previous study (DIMS group), and 55 who were switched from using a single vision spectacle lens for two years to the MiyoSmart spectacle lens in the third year of the study (Controlto-DIMS group). Historical controls were age matched to the DIMS group at 24 months and used for comparing the third-year changes. The study concluded that the treatment effect was sustained over 36-months for both SER and axial elongation in children who had been wearing MiyoSmart lenses for three years (Figure 4). The children who switched from wearing single vision spectacle lenses to MiyoSmart spectacles (Control-to-DIMS) after 24 months, demonstrated a significant slowdown in both myopia progression and axial elongation. Their changes in SER and AL in the third year were comparable to the first-year changes in the DIMS group. In the third year, 80% of the subjects in the DIMS group progressed by less than -0.50D in the third year, compared with 87% in the Control-to-DIMS group. Only 5% and 2% in the DIMS and Control-to-DIMS groups respectively, had myopia progression of more than -1.00D. In the DIMS and Control-to-DIMS groups, 52% and 58% respectively, had axial elongation less than 0.1mm (Figure 5). Figure 4. (A) Changes in SER and AL from baseline to 36 months. The red dotted line represents the period (24–36 months) during which the previous single vision control group wore DIMS spectacle lenses. (B) The third-year changes in SER and AL in the DIMS and Control-to-DIMS groups. The green line shows the 12-month changes in SER and AL in the historical control group. Figure 5. Distributions of myopia progression and axial elongation in the third year. All these findings showed that the myopia control effect was achieved even though the subjects started to wear DIMS lenses at an older age. Six-Year Follow-Up Clinical Study 5Due to the COVID pandemic, the study was officially closed at three and a half years, and the children were free to continue wearing MiyoSmart spectacles or stop treatment and wear single-vision spectacle lenses. After the Centre for Myopia research was reopened, the researchers decided to continue following the children’s progress with the aim to monitor clinical performance and safety over time. This six-year follow-up clinical study became the longest clinical study for myopia spectacle lenses to date. The Children were divided into four groups: Group 1 wore MiyoSmart spectacles for a total of six years (including the first two years in RCT). Group 2 wore MiyoSmart spectacles for the first 3.5 years and then changed to wearing single vision spectacles afterward. Group 3 wore single vision spectacles in the first two years of the RCT and switched to wearing MiyoSmart spectacles afterwards, for the remaining four years. Group 4 wore single vision spectacles in the first two years of RCT, switched to wearing MiyoSmart spectacles in the third year, and then switched back to wearing single vision spectacles until the end of the six-year period (Figure 6). Changes in SER and AL over the six years were analysed and compared. In total, 90 children completed the data collection for a period of six years. The children in group 1 who had worn MiyoSmart for six years had a cumulative progression of -0.92D (SER) and 0.6mm (AL) on average (Tables 1 and 2).5For the children in groups 2, 3, and 4, who had varying intervals of wearing MiyoSmart or single vision lenses during the six years, it was found that myopia progression slowed down during the periods of wearing MiyoSmart, while a relative faster progression occurred while wearing single vision lenses. It was also noted that the children who switched from wearing MiyoSmart to single vision lenses did not experience a rebound effect based on the average axial elongation data.5,6,7Figure 6. Different groups and subject numbers of six-year follow up study. Table1. Summary of data for the subjects who completed the six-year followup study. The grey blocks represent the period of wearing single vision spectacle lenses and the uncoloured blocks represent the time wearing DIMS spectacle lenses. Table 2. Cumulative changes in the cycloplegic spherical equivalent refraction (SER) from baseline to 72 months in Groups 1–4. The grey blocks represent the period of wearing single vision spectacle lenses and the uncoloured blocks represent the time of wearing DIMS spectacle lenses. Figure 7. Aged-related axial growth rates under various myopia management interventions plotted alongside emmetropic growth curves. DIMS was found to restore emmetropic eye growth.11symposium at the 18th International Myopia Conference (IMC), in The Netherlands in September this year. A rebound effect is defined as accelerated eye growth, respectively losing the treatment success after discontinuing treatment, compared to an age-normative untreated group.8,9Study ConclusionsThe findings of the six-year, long-term followup study proved the myopia control effect of the MiyoSmart spectacle lens is sustained over time for children wearing the lens. It also confirmed that patients who stop wearing MiyoSmart lenses show no rebound effects when compared to the initial myopia rates of progression during the two-year randomised control trial or with the general population. • The myopia control effect of MiyoSmart spectacle lens is sustained over six years. • Average cumulative myopia progression less than -1.00D (-0.92D or -0.15D/year) and average axial elongation 0.60mm (0.10mm/ year) over six years in DIMS group. • Children who stopped wearing MiyoSmart spectacle lenses show no rebound effect. EXPLORING FURTHERProfessor Hakan Kaymak of the Internationale Innovative Ophthalmochirurgie in Duesseldorf, Germany, presented the findings of his study on axial length growth under treatment with MiyoSmart spectacle lenses in Germany and proposed a new definition of a treatment goal in myopia management. 10Prof Kaymak questioned, “What is the goal of treatment in children with myopia progression?” He stated that children's eyes grow, even if they stay emmetropic in their childhood. This means emmetropic eye growth that corresponds to normal physiological growth should be seen as our new treatment goal. This concept of comparing efficacy to the emmetropic eye growth was also presented by Paul Chamberlain during the CooperVision With the support of different large cohort studies, we now know how the eyes grow in childhood compared to the child’s age. To understand the relationship between the emmetropic eye growth and how various myopia control treatments compared to this, Prof Kaymak plotted the physiological (emmetropic) growth line together with the results from the DIMS 3-year clinical study, as well as study results from various myopia control treatments including contact lenses, and atropine where the treatment effect is dose dependent. He found that when comparing data from the MiyoSmart (DIMS) 3-year follow-up clinical study, the children wearing MiyoSmart restored physiological eye growth. The higher the addition for contact lenses or higher the atropine dose, the better the control effect observed (Figure 7).11Prof Kaymak also showed that the MiyoSmart treatment success is comparable under real-world conditions in his clinic; and furthermore, that the safety with MiyoSmart and the visual performance did not change when atropine 0.01% daily was added.11,12He concluded that in cases where the treatment goal is not reached with MiyoSmart alone, combination treatment with atropine could increase the control effect. Additionally, Prof Carly Lam shared how myopia control effect may be influenced by baseline relative peripheral refraction in children wearing the MiyoSmart spectacle lens with D.I.M.S. Technology.11The results showed that myopia control effect was stronger in children with baseline hyperopic RPR than in children with baseline myopic RPR. 11Influences of baseline RPR in myopia control effects by MiyoSmart was sustained over the six years. The study provided one possible scientific explanation to the clinical question of why some children achieve a better myopia control outcome than others. It also demonstrated that measuring RPR in clinical practice could allow for more precise prescribing of a treatment strategy and its potential control effect. CONCLUSIONHaving completed the longest running clinical study of myopia spectacle lenses, Hoya has demonstrated an average cumulative myopia progression of less than -1.00D (-0.92D or -0.15D/year) and average axial elongation 0.60mm (0.10mm/year) over six years for children wearing MiyoSmart. 5As such, it can be concluded that long-term use of MiyoSmart is an effective, safe, and non-invasive form of myopia management for children. The results from the six-year follow-up study show scenarios that may be commonly seen in real life, such as children beginning treatment later after several years of progression combined with single vision lens wear, as well as children stopping treatment after a few years of wear. Children who switched to MiyoSmart spectacle lenses showed a significant slowdown effect and the benefit of starting the treatment at any time. However, wearing MiyoSmart for as long as the child may be progressing is clearly the best course of action and provides the most effective outcome. To earn your CPD hours from this article, visit mieducation.com/MiyoSmart-the-partnership-thatinspired-a spectacle-lens-revolution. References 1. The Nobel Prize in Physiology or Medicine 2003. https:// www.nobelprize.org/prizes/medicine/2003/summary/ (accessed 11.10.2022) 2. Based on number of MiyoSmart lenses sold per Hoya sales data on file as of June 2022. 3. 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. 4. Lam CS, Tang WC, Lee PH, et al. 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 Published Online First: 17 March 2021. doi: 10.1136/bjophthalmol-2020-317664. 5. Lam CSY, Tang WC, Zhang HY, Tse DYY, To CH. Myopia control in children wearing DIMS spectacle lens: 6 years results. Invest Ophthalmol Vis Sci. 2022;63(7):4247. 6.Wong HB, Machin D, Tan SB, Wong TY, Saw SM. Ocular component growth curves among Singaporean children with different refractive error status. Invest Ophthalmol Vis Sci. 2010 Mar;51(3):1341-7. doi: 10.1167/iovs.09-3431. Epub 2009 Oct 29. PMID: 19875656. 7.Chamberlain, P, Lazon de la Jara, P, Arumugam, B, & Bullimore, MA. Axial length targets for myopia control. Ophthalmic Physiol Opt. 2021; 41: 523– 531. https://doi. org/10.1111/opo.12812. 8.Wolffsohn JS, Kollbaum PS, Berntsen DA, et al. IMI – Clinical Myopia Control Trials and Instrumentation Report. Invest Ophthalmol Vis Sci. 2019;60:M132–M160. https:// doi.org/10.1167/iovs.18-25955. 9.Chia A, Lu QS, Tan D. Five-year clinical trial on atropine for the treatment of myopia 2: myopia control with atropine 0.01% eyedrops. Ophthalmology. 2016; 123:391–399. 10. Kaymak, H., Graff, B., Neller, K. et al. Myopietherapie und Prophylaxe mit „Defocus Incorporated Multiple Segments “-Brillengläsern. Ophthalmologe 118, 1280– 1286 (2021). https://doi.org/10.1007/s00347-021-01452-y. 11. Kaymak H, Lembo A, Lam CSY. Hoya Vision Care Myopia Symposium. New Insights to Advance Myopia Management: Axial length growth under therapy with MiyoSmart spectacle lenses; A comparison of myopia control in European children with Defocus Incorporated Multiple Segments (DIMS) spectacles, atropine, and combined DIMS/atropine; Myopia control effect is influenced by baseline relative peripheral refraction in children wearing Defocus Incorporated Multiple Segments (DIMS) spectacle lenses. International Myopia Conference (IMC) 2022, 4 September, Rotterdam, The Netherlands. 12. Mattern A.-I., Kaymak H., Graff B., Neller K., Langenbucher A., Seitz B., Schwahn H. Verkehrssicherheit von DIMS-Brillengläsern und Atropin in der Kombinationstherapie zur Hemmung der Myopieprogression. Poster at Deutsche Ophthalmologische Gesellschaft (DOG) 2022, 29.09- 02.10.2022, Berlin, Germany.Ulli Hentschel is the Training and Development manager for Hoya Lens Australia. Mr Hentschel manages professional services as well as being the product manager for MiyoSmart. He has led the introduction of MiyoSmart into the Australian and New Zealand markets and has been working closely with global and local key opinion leaders in myopia management as well as other industry leaders to drive the topic of myopia management for the past four years. Case Study WRITER Jagrut Lallu Anthony,* an 11-year-old white male of European descent first attended my clinic in New Zealand for examination at the age of three on 13 January 2014. Anthony has one myopic parent (-4.00DS who began myopic progression at age eight). We recorded a +1.25/-0.50x65 in the OS eye following cycloplegic refraction. The OD eye also had a similar degree of hyperopia (+1.00DS). Both eyes remained stable until March 2020. Following six months of increased screentime, Anthony’s refraction and axial lengths altered in the following manner in the OS eye, with similar results in the OD eye: 30 July 2019: +1.25/-0.50x65 23.81mm. 20 March 2020: +0.75/-0.50x65 23.92mm. Three days later New Zealand entered the first COVID lockdown. 23 December 2020: -0.50/-0.75x65 24.15mm. Intervention with MiyoSmart spectacle lenses commenced. 15 September 2021: -0.75/-1.25x58 24.16mm. 08 February 2022: -0.75/-1.25x58 24.17mm. Notable Learnings From This Case: • Lockdowns, increased near work and a change to Anthony’s daily environment had a noticeable effect, • After high progression in the previous years, a significant slowing of axial length and relative refraction was achieved with the intervention of MiyoSmart DIMS spectacle lenses, • Regular reviews, using all available tools related to the management of myopia were essential to measure and demonstrate relative myopic change. Key Practitioner Learnings: • Review suspicious cases at least six-monthly for refractive change, • Where possible use technology, such as axial length measurement to aid management decisions, and• Use support networks to discuss cases. *Patient name changed for anonymity. Jagrut Lallu (Hons) MSc is an optometrist and is a partner of Rose Optometry in Hamilton, New Zealand.

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