Summary of All the MiYOSMART Studies

An innovative way to manage myopia in children 

The increasing prevalence of myopia in children is a topic that has gained a high level of attention among many, especially the parents of myopic children. By recommending MiYOSMART spectacle lens, you are following an innovative ¹ and evidence-based myopia management. Here you can find a summary of all the studies and scientific documentation involving MiYOSMART to date. 

Our scientific partner: The Hong Kong Polytechnic University 

HOYA Vision Care has worked in close partnership with The Hong Kong Polytechnic University research team since 2014. Together, we developed the innovative¹ 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 researchers³ In 2002, Professor Chi Ho To and Professor Carly Siu Yin Lam and their research team developed the defocus incorporated soft contact (DISC) lens, one of the pioneering products for myopia control selling across China.⁴

The theoretical fundamentals: the defocus theory 

The defocus theory 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 therapy option.⁵

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.^6-7

Further reading and summaries of the IMI White Papers, as well as their translations, can be found on the IMI website⁸

Current MiYOSMART research: scientific evidence for effectiveness and safety 

The Hong Kong Polytechnic University carried out two studies demonstrating the effectiveness and safety of MiYOSMART 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.^9-10 These studies are open to the public, so everyone can access the research.  

Subsequently, the data from the 6-year follow-up study was published in spring of 2023 in Scientific Reports. 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

Recently, a new observational study in the UK demonstrated effectiveness in Caucasian children over a 12-month period, particularly in 10‒15 year olds.¹² A full publication of the 2-year results is due to be released in 2024. Additionally, one-year data from an independent randomised controlled trial in China has been presented at the ARVO 2023 conference.¹³

Further studies verified the safety and tolerability of MiYOSMART, and the properties of D.I.M.S. Technology: 

• The adaptation and acceptance of defocus incorporated multiple segment lens for  Chinese children¹⁴ 
• Optical and imaging properties of a novel multi-segment spectacle lens designed to  slow myopia progression¹⁵

• Vision tests on spectacle lenses and contact lenses for optical myopia correction: a pilot study¹⁶
• Safety of DIMS spectacle lenses and atropine as combination¹⁷
• Controlling the growing problem of myopia in children¹⁸
• Synergistic effects of defocus-incorporated multiple segments and atropine in slowing the progression on myopia¹⁹
• A comparison of myopia control in European children and adolescents with defocus incorporated multiple segments (DIMS) spectacles, atropine, and combined DIMS/atropine²⁰

Myopia control options: MiYOSMART comparison with other myopia management solutions 

Two papers published in 2021, Efficacy in myopia control and Myopia treatment and  prophylaxis with defocus incorporated multiple segments spectacle lenses discuss the effectiveness of MiYOSMART compared with other options in myopia management.^21-22

Acceptance Worldwide and in Europe 

The World Society of Pediatric Ophthalmology and Strabismus and the IMI endorsed MiYOSMART spectacle lenses with D.I.M.S. Technology as an effective myopia management solution.^23-24 Update and guidance on management of myopia from the European Society of Ophthalmology is the most recent reference for myopia management in Europe.⁶

Conclusion: MiYOSMART is a safe and effective method of myopia  management in children^9-11

More than four million MiYOSMART spectacle lenses have been sold across the world with the innovative D.I.M.S. Technology.^1,25 The successes of this new method are continuously observed and evaluated by eye specialists, the affected families and the scientific community. The currently published research results from the various sources support MiYOSMART as an effective method for slowing down myopia progression.^9-11

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. 

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: 28/06/2023). 
• 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: 28/06/2023). 
• 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: 28/06/2023). 
• 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 HY, Lee PH, Tse DYY, Qi H, Vlasak N, To CH. Long-term myopia control effect and safety in children wearing DIMS spectacle lenses for 6 years. Sci Rep. 2023 Apr 4;13(1):5475.  
• 12. McCullough S, Barr H, Fulton J, et al. 2-Year Multi-Site Observational Study of MiYOSMART myopia control spectacle lenses in UK children:1-year results (Abstract). ARVO 2023. 23-27 April 2023. New Orleans, LA, USA.  
• 13. Liu L, Li X. Myopia progression and visual performance of Chinese children wearing Defocus Incorporated Multiple Segments Spectacle Lens (DIMS) (Abstract). ARVO 2023 23-27 April 2023. New Orleans, LA, USA.   
• 14. 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. 
• 15. 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. 
• 16. 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. 
• 17. 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. 
• 18. 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: 28/06/2023). 
• 19. Huang Z, Chen XF, He T, Tang Y, Du CX. Synergistic effects of defocus-incorporated multiple segments and atropine in slowing the progression of myopia. Sci Rep. 2022 Dec 24;12(1):22311. doi: 10.1038/s41598-022-25599-z. Erratum in: Sci Rep. 2023 Jun 14;13(1):9650.  
• 20. Nucci P, Lembo A, Schiavetti I, Shah R, Edgar DF, Evans BJW. A comparison of myopia control in European children and adolescents with defocus incorporated multiple segments (DIMS) spectacles, atropine, and combined DIMS/atropine. PLoS One. 2023 Feb 16;18(2):e0281816. doi: 10.1371/journal.pone.0281816.  
• 21. 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. 
• 22. Kaymak, H., Graff, B., Neller, K. et al. Myopia treatment and prophylaxis with defocus incorporated multiple segments spectacle lenses [German]. Ophthalmologe. 2021;118:1280-1286. doi: 10.1007/s00347-021-01452-y. 
• 23. WSPOS. Myopia Consensus Statement 2023. 2023. Available from: https://www.wspos.org/swdcore/uploads/WSPOS-Myopia-Consensus-Statement-2023-1.pdf (Last accessed: 28/06/2023). 
• 24. Jong M, Jonas JB, Wolffsohn JS, et al. IMI 2021 Yearly Digest. Invest Ophthalmol Vis Sci. 2021;62(5):7. doi: 10.1167/iovs.62.5.7.  
• 25. Based on number of MiYOSMART lenses sold per Hoya sales data on file as of December 2022.