Summary of all the MiYOSMART studies

MiYOSMART Spectacle Lenses    Confidence in prescribing, backed by evidence

 

MiYOSMART spectacle lenses are an innovative¹ myopia management solution incorporating Defocus Incorporated Multiple Segment (D.I.M.S.) Technology based on solid peripheral hyperopic defocus theory. After 7 years on the market, the spectacle lenses are backed by a robust body of evidence, with over 90 scientific publications to-date. This article provides an overview of the robust MiYOSMART evidence base, with linked scientific publications for your convenience.

 

Our scientific partner: The Hong Kong Polytechnic University

HOYA Vision Care has been collaborating with The Hong Kong Polytechnic University research team for many years. Together, we developed D.I.M.S. Technology, which forms the basis for myopia management with MiYOSMART.

The Hong Kong Polytechnic University has an excellent reputation in the scientific field, with over 30 years of experience in myopia research. It is also one of the Top 100 universities worldwide.² Six of their scientists are listed among the 200 internationally leading myopia researchers.³ In 2002, Professor Chi Ho To and Professor Carly Siu Yin Lam and their research team developed the Defocus Incorporated Soft Contact (DISC) lenses,⁴ one of the pioneering products for myopia control selling across China.

 

The theoretical fundamentals: peripheral hyperopic defocus theory

The peripheral hyperopic defocus theory suggested in the 1970s is the current, internationally accepted theory for explaining induced myopia progression due to single-vision spectacle lenses. This theory is based on various animal and human studies, which confirm that hyperopic defocus increases myopia progression, and thus supports myopic peripheral defocus as a viable treatment solution.^5-8

The defocus theory is supported by leading researchers in the guidance from the European Ophthalmological Society and in the International Myopia Institute (IMI) White Paper, IMI - Report on Experimental Models of Emmetropization and Myopia.^9,10

Further reading and summaries of the IMI White Papers, as well as their translations, can be found on the IMI website.¹⁰

 

Efficacy of MiYOSMART spectacle lenses

Numerous studies have demonstrated the effectiveness of MiYOSMART controlling myopia progression. A 2-year randomized controlled clinical trial conducted by Lam et al. (2020) found that D.I.M.S. Technology spectacle lenses slowed myopia progression by on average 60% compared to single-vision lenses.¹¹ Subsequent follow-up studies carried out at the 3- and 6-year timepoints found sustained myopia control effects without rebound effect upon discontinuation.^12,13  Results of an 8-year follow-up study show further long-term progression stability, with an average myopia progression of less than -0.5D over 8 years.^14*

_{*Based on the results of 11 participants in the 8-year DIMS group who wore DIMS spectacle lenses for the entire 8 years.}

MiYOSMART spectacle lenses have been shown to deliver effective myopia management for children of various ethnic backgrounds, having been studied in many Asian and European countries.^11,15,16 MiYOSMART spectacle lenses effectively slowed down myopia progression in Caucasian children over 2 years.^15,16 Compared with by-age and by-race model of untreated myopic eye growth, DIMS spectacle lenses effectively slowed eye growth in most UK children in both year 1 and year 2 wear.^15,16

Recent studies have shown that the use of MiYOSMART spectacle lenses may reduce the cost of treating ocular complications in the future,^17,18 and may reduce the development of severe vision impairment** by almost 20% over a lifetime.^17,18

_{**defined as visual acuity worse than 20/200}

 

Further papers verified the effectiveness of MiYOSMART, and the properties of D.I.M.S. Technology:

• Defocus Incorporated Multiple Segments Spectacle Lenses Changed the Relative Peripheral Refraction: A 2-Year Randomized Clinical Trial¹⁹
• Evaluation of an Optical Defocus Treatment for Myopia Progression Among Schoolchildren During the COVID-19 Pandemic²⁰
• Myopia Control Effect Is Influenced by Baseline Relative Peripheral Refraction in Children Wearing Defocus Incorporated Multiple Segments (DIMS) Spectacle Lenses²¹
• One-year Efficacy of the Defocus Incorporated Multiple Segment Lens in Chinese Myopic Children²²
• Changes in relative peripheral refraction in children who switched from single-vision lenses to Defocus Incorporated Multiple Segments lenses²³
• The Efficacy of Defocus Incorporated Multiple Segments Lenses in Slowing Myopia Progression: Results from Diverse Clinical Circumstances²⁴
• Age-matched analysis of axial length growth in myopic children wearing defocus incorporated multiple segments spectacle lenses²⁵
• Effect of defocus incorporated multiple segments lenses on halting myopia progression not responding to low-concentration atropine (0.01%) eye drops²⁶
• Overview on Defocus Incorporated Multiple Segments Lenses: A Novel Perspective in Myopia Progression Management²⁷

 

Further research looking at cost-effectiveness:

• Cost-Effectiveness Analysis of Myopia Progression Interventions in Children²⁸

 

 

High acceptance, tolerability and adaptability

Multiple papers discuss the safety and acceptance of the MiYOSMART spectacle lenses. Lam et al (2020) found that the DIMS spectacle lenses did not cause any adverse event on visual function,²⁹ also supported by findings of Kaymak et al (2022).³⁰ The adaptation and acceptance of MiYOSMART was also researched, finding that any visual adverse events were mild and transient.³¹ A further study showed that children’s vision-related quality of life while wearing MiYOSMART spectacle lenses is comparable to single vision spectacle lenses.³²

A recent study found that most children and their parents prefer MiYOSMART spectacle lenses over atropine drops or contact lenses for myopia management, due to their non-invasive and convenient nature.³³

Further research into the safety, tolerability and acceptance can be found below:

• Effects of Orthokeratology Lens Compared to Defocus Incorporated Multiple Segments Lens for Adolescent Myopia and Factors Related to Corneal Injury³⁴
• Exploring the impact of optical corrections on visual functions in myopia control-a scoping review³⁵
• Comparison of optical myopia control interventions: effect on peripheral image quality and vision³⁶

 

MiYOSMART in the wider myopia management landscape

The MiYOSMART spectacle lenses entered the market in 2018, at a time when the need for more innovative solutions was at its peak. As such, there are many reviews and comparison studies involving the D.I.M.S. Technology spectacle lenses, which aim to guide prescribers to the most appropriate treatment solution for their young myopic patients.

The reviews exploring the myopia management landscape, as well as MiYOSMART’s place in the treatment paradigm can be found here:

• Effectiveness of peripheral defocus spectacle lenses in myopia control: a Meta-analysis and systematic review³⁷
• Interventions for myopia control in children: a living systematic review and network meta‐analysis. Cochrane Database of Systematic Reviews 2023³⁸
• Efficacy in myopia control³⁹
• Myopia Control: Are we ready for an evidence-based approach?⁴⁰
• Effectiveness of myopia control interventions: A systematic review of 12 randomized control trials published between 2019 and 2021⁴¹
• High myopia: Reviews of myopia control strategies and myopia complications⁴²
• Preventing the Progression of Myopia in Children—A Review of the Past Decade⁴³
• New Designs of Spectacle Lenses for the Control of Myopia Progression: A Scoping Review⁴⁴
• Peripheral Defocus and Myopia Management: A Mini-Review⁴⁵

Furthermore, there are multiple studies exploring MiYOSMART effectiveness and safety as compared to other treatment solutions:

• Myopia control: short term effect of 0.01% atropine vs. defocus incorporated multiple segment lenses—a retrospective study in European children⁴⁶
• Comparison of myopic control between orthokeratology contact lenses and defocus incorporated multiple segments spectacle lenses⁴⁷
• Different efficacy in myopia control: Comparison between orthokeratology and defocus-incorporated multiple segment lenses⁴⁸
• Comparison of the long-term effects of atropine in combination with Orthokeratology and defocus incorporated multiple segment lenses for myopia control in Chinese children and adolescents⁴⁹
• Effectiveness of orthokeratology and myopia control spectacles in a real-world setting in China⁵⁰
• Comparing the effects of highly aspherical lenslets versus defocus incorporated multiple segment spectacle lenses on myopia control⁵¹
• Multiple segment spectacle lenses for myopia control. Part 2: Impact on myopia progression⁵²

 

MiYOSMART in combination with atropine

Studies have shown that combining MiYOSMART spectacle lenses with low-dose atropine (0.01%) can enhance the myopia control effect.^53-56 One study, published in 2023, showed that the combination treatment reduced axial elongation by 72% compared to single-vision lenses.⁵³ Further research also suggests that MiYOSMART spectacle lenses are safe to be used in combination with low dose atropine, including when participating in road traffic.⁵⁷

A more recent study showed that over 12 months approximately 2 out of 5 children treated with combination of MiYOSMART and 0.025% atropine eye drops had no myopia progression over 12 months.⁵⁶

 

Optical and Imaging Properties of D.I.M.S. Technology

The development of D.I.M.S. Technology is grounded in robust theoretical and empirical research. The following studies provide a deeper understanding of the mechanisms and principles behind their design:

• Optical and imaging properties of a novel multi-segment spectacle lens designed to slow myopia progression⁵⁸
• Multiple segment spectacle lenses for myopia control. Part 1: Optics⁵⁹
• Multiple segment spectacle lenses for myopia control. Part 2: Impact on myopia progression⁶⁰
• Modelling the refractive and imaging impact of multi-zone lenses utilised for myopia control in children's eyes⁶¹
• Retinal shadows produced by myopia control spectacles⁶²
• Optical characterization of two novel myopia control spectacle lenses⁶³

 

Conclusion: MiYOSMART is a safe and effective method of myopia management in children

Over 12 million MiYOSMART spectacle lenses have been sold globally, in over 40 countries.^64,65 The currently published research results from a continuous commitment to provide robust and quality evidence to support MiYOSMART as an effective method for slowing down myopia progression.^11-14

You can be confident that MiYOSMART spectacle lenses demonstrate:

• I.M.S Technology stemming from the widely accepted peripheral hyperopic defocus theory^9,66
• Sustained long-term effectiveness with no rebound effect^{15, 67-69}
• High acceptance, tolerability and adaptability^31,70 with no impact on social relationships or ability to spend time outdoors^32,33
• Improved outcomes in combination treatment with atropine^53,54,56,57
• Efficacy in children of different ethnicities and age groups^11,15,16

HOYA Vision Care’s continuous commitment to providing new evidence supports eye care professionals in everyday practice to provide confident solutions for myopic children so they can live their brightest futures.

Further clinical studies are currently running. As soon as results are published, we will update our documentation and inform you. Our experts are happy to provide further information and are available to exchange of experiences.

The fundamentals: the peripheral defocus theory

The peripheral defocus theory is the current, internationally accepted theory for explaining induced myopia progression due to the usage of single vision spectacle lenses. This theory is based on various animal and human studies, which confirm that peripheral hyperopic  defocus increases myopia progression and thus supports peripheral myopic defocus as a treatment option.⁵

The peripheral defocus theory is supported  by leading researchers in the guidance from the European Ophthalmological Society⁶ and in the International Myopia Institute (IMI) White Paper, IMI - Report on Experimental Models of Emmetropization and Myopia.^6,7

Further reading and summaries of the IMI White Papers, as well as their translations into various languages, can be found on the IMI website.⁸

 

Current MiYOSMART research: scientific evidence for effectiveness and safety

The Hong Kong Polytechnic University carried out two studies demonstrating the efficacy⁹ and effectiveness¹⁰ of MiYOSMART spectacle lenses: a 2-year, randomised double-blind study and a 3-year follow-up study, which were published in  the reputable British Journal of Ophthalmology. These studies are open to the public, so everyone can access the research.

Subsequently, the data from the 6-year follow-up study was presented at the Association for Research in Vision and Ophthalmology (ARVO) meeting in 2022 held in Denver, USA. The data showed that over six years, the control effect was sustained and there was no rebound effect in the children who stopped wearing MiYOSMART.¹¹

Further studies verified different aspects of MiYOSMART spectacle lens performance such as tolerability, safety and optical properties:

• The adaptation and acceptance of defocus incorporated multiple segment lens for Chinese children¹²
• Optical and imaging properties of a novel multi-segment spectacle lens designed to slow myopia progression¹³
• Vision tests on spectacle lenses and contact lenses for optical myopia correction: a pilot study¹⁴
• Safety of DIMS spectacle lenses and atropine as combination¹⁵
• Controlling the growing problem of myopia in children¹⁶

 

Myopia control options: MiYOSMART comparison with other myopia management solutions

Two papers published in 2021, Efficacy in myopia control¹⁷ and Myopia treatment and  prophylaxis with defocus incorporated multiple segments spectacle lenses¹⁸ discuss the effectiveness of MiYOSMART compared with other options in myopia management. While a recent study from 2022 shows the synergistic effect when MiYOSMART is combined with atropine¹⁹.

Further clinical studies are currently running. As soon as results are published, we will update our MiYOSMART related materials and inform you.

Disclaimer: MiYOSMART is not approved for myopia management in all countries, including the United States, and is not currently available for sale in all countries, including  the United States.

Sources:

1.     Patent protected in China (ZL 201310628174.8), Hong Kong (1210838), and the United States (10268050 & 11029540).

2.     The Hong Kong Polytechnic University. QS World University Rankings. 2023. Available from: https://www.topuniversities.com/universities/ivanovo (Last accessed: 04/01/2023)

3.     Six PolyU researchers ranked in the Top 200 in optometry. The Hong Kong Polytechnic University. April 2021. Available from: https://www.polyu.edu.hk/publications/pulse-polyu/issue/202104/achievements/six-polyu-researchers-ranked-in-the-top-200-in-optometry (Last accessed: 04/01/2023)

4.     Lam CS, Tang WC, Tse DY, Tang YY, To CH. Defocus Incorporated Soft Contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomised clinical trial. Br J Ophthalmol. 2014;98(1):40-5. doi:10.1136/bjophthalmol-2013-303914

5.     Berntsen DA, Barr CD, Mutti DO, Zadnik K. Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses. Invest Ophthalmol Vis Sci. 2013;54(8):5761-70. doi:10.1167/iovs.13-11904.

6.     Németh J, Tapasztó B, Aclimandos WA, et al. Update and guidance on management of myopia. European Society of Ophthalmology in cooperation with International Myopia Institute. Eur J Ophthalmol. 2021;31(3):853-883. doi:10.1177/1120672121998960.

7.     Troilo D, Smith EL 3rd, Nickla DL, et al. IMI - Report on Experimental Models of Emmetropization and Myopia. Invest Ophthalmol Vis Sci. 2019;60(3):M31-M88. doi:10.1167/iovs.18-25967

8.     IMI White Papers & Clinical Summaries. International Myopia Institute. 2023. Available from:  https://myopiainstitute.org/imi-white-papers/ (Last accessed: 04/01/2023)

9.     Lam CSY, Tang WC, Tse DY, et al. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020;104(3):363-368. doi:10.1136/bjophthalmol-2018-313739

10.  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. Br J Ophthalmol. 2022;106(8):1110-1114. doi:10.1136/bjophthalmol-2020-317664

11.  Lam CSY, Tang WC, Zhang A, Tse D, To CH. Myopia control in children wearing DIMS spectacle lens: 6 years results (Abstract). Invest Ophthalmol Vis Sci. 2022;63(7):4247. Available from: https://iovs.arvojournals.org/article.aspx?articleid=2781769 (Last accessed: 04/01/2023)

12.  Lu Y, Lin Z, Wen L, et al. The Adaptation and Acceptance of Defocus Incorporated Multiple Segment Lens for Chinese Children. Am J Ophthalmol. 2020;211:207-216. doi:10.1016/j.ajo.2019.12.002

13.  Jaskulski M, Singh NK, Bradley A, Kollbaum PS. Optical and imaging properties of a novel multi-segment spectacle lens designed to slow myopia progression. Ophthalmic Physiol Opt. 2020;40(5):549-556. doi:10.1111/opo.12725

14.  Kaymak H, Neller K, Schütz S, et al. Vision tests on spectacle lenses and contact lenses for optical myopia correction: a pilot study. BMJ Open Ophthalmol. 2022;7(1):e000971. Published 2022 Apr 5. doi:10.1136/bmjophth-2022-000971

15.  Kaymak H, Mattern AI, Graff B, et al. Safety of DIMS Spectacle Lenses and Atropine as Combination Therapy for Myopia Progression. Sicherheit von Brillengläsern mit DIMS-Technologie und Atropin in der Kombinationstherapie der Myopieprogression. Klin Monbl Augenheilkd. 2022;239(10):1197-1205. doi:10.1055/a-1930-7116.

16.  Kaymak H. Controlling the growing problem of myopia in children. November 2022. Available from: https://europe.ophthalmologytimes.com/view/controlling-the-growing-problem-of-myopia-in-children (Last accessed: 04/01/2023)

17.  Brennan NA, Toubouti YM, Cheng X, Bullimore MA. Efficacy in myopia control. Prog Retin Eye Res. 2021;83:100923. doi:10.1016/j.preteyeres.2020.100923

18.  Kaymak H, Graff B, Neller K, Langenbucher A, Seitz B, Schwahn H. Myopietherapie und Prophylaxe mit „Defocus Incorporated Multiple Segments“-Brillengläsern [Myopia treatment and prophylaxis with defocus incorporated multiple segments spectacle lenses]. Ophthalmologe. 2021 Dec;118(12):1280-1286. German. doi: 10.1007/s00347-021-01452-y.

19.  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

20.  Based on number of MiYOSMART lenses sold per Hoya sales data on file as of June 2022.