ZEISS Myopia Management Now Available in Europe

February 2023

From April 2023, ZEISS solutions for the management of progressive myopia will also be available in Europe. Years of research show that prevalences differ and the risks associated with progressive myopia require specific solutions for different target groups. The new ZEISS MyoCare lenses will become an essential building block in the management of progressive myopia.

Both myopia and progressive myopia are affecting more and more people worldwide. This has led to a big effort by industry and optometry experts to expand diagnostic and management options. With a projected prevalence of 50 percent of the world's population by 2050*, myopia is a global challenge. However, there are regional differences. While up to 90 percent of the urban youth of 20 years and younger are affected in Southeast Asia, case rates in Europe are much lower. The causes of progressive myopia in particular also vary to some extent by region and country, according to current evidence.

ZEISS is therefore combining more than ten years of extensive experience with progressive and high myopia in Asia with scientifically-based findings to offer effective, specific myopia management solutions in Europe as well.

Science and research fundamental

To better understand the causes and treatment options for effective intervention of progressive myopia, further research and scientific developments are essential. ZEISS has more than ten years of experience in basic and clinical research and the successful use of ZEISS Myopia Management in Southeast Asia. "The research group at the ZEISS Vision Science Lab at the University of Tübingen, Germany, and the collaboration with international scientific institutions as well as the developers at ZEISS form the basis of our innovations for myopia management," says Dr. Arne Ohlendorf, researcher at the ZEISS Vision Science Lab focusing on myopia development.

One example of the collaboration is the cooperation with the "LIFE Child Study" at the University of Leipzig, Germany, which ZEISS has been supporting since 2014. This study is one of the largest, longitudinal cohort studies with children in Europe and serves to identify the essential factors for health and disease in children and adolescents, with a focus on diseases of civilization. With the support of ZEISS, the study is also tracking development of vision in participating children of Caucasian origin. The eye health cohort consists of 1,965 children and adolescents, aged 3 to 18, who are measured annually over 10 years for visual acuity, refractive status and eye length. "The most important finding is that the prevalence for myopia in Germany is much lower than in East Asia," says Dr. Ohlendorf.

Furthermore, ZEISS evaluated data from everyday life to gain an even deeper understanding of the real situation. ZEISS has studied the development of refractive status in more than 500,000 children and adolescents between 0 and 20 years of age together with Euronet Market Research. The database contains data from over 400 eye care professionals in Germany. The reference curves for refractive development in children of Caucasian origin are based on more than 1.3 million data points and allow individual prediction of refractive errors based on the history and refraction of the individual child. "Again, it shows that the prevalence in Europe is much lower than in China, for example," Ohlendorf said. In Asia, myopia occurs significantly more frequently and at a younger age than in Europe, for example, caused not only by genetic predisposition but also by a different daily routine with longer learning phases, more indoor and fewer outdoor activities.

On average, the prevalence of high myopia is 5 percent and myopia among children and adolescents up to 20 years of age in Asia is up to 90 percent, whereas in Germany the prevalence of myopia for children aged 3 to 16 is approximately 10 %. The vast majority of myopic children in Europe will therefore not be affected by progressive myopia, but will continue to benefit from the provision of single vision lenses.

A stringent anamnesis and data recording of children at risk is essential in order to have a reliable decision basis.

"Every diopter matters, every child counts"

This motto of the International Myopia Conference 2022 applies to professional myopia management everywhere. To assess an individual's risk for progressive or high myopia, careful anamnesis and observation of the individual child is essential. "Every child counts, and every diopter matters," emphasizes Dr. Katharina Breher, a scientist specializing in physiological optics at the ZEISS Vision Science Lab at the University of Tübingen, Germany. "Every tenth of a millimeter of eye length that can be avoided should be avoided." Myopia management is necessary to reduce the risk of potential effects that can occur at a later stage because it is largely caused by excessive eye growth. An overly long eye is associated with an increased risk of various eye diseases with potentially irreversible vision loss. For example, the risk of retinal detachment is increased by a factor of 3 (for 3 D), and macular degeneration is approximately 350 times more common in myopes and occurs early in midlife.

"The assessment for or against myopia management in an individual case can be complex," says Dr. Arne Ohlendorf. "This is because the distinction between physiological growth,which is normal eye growth in the course of emmetropization, and growth requiring treatment is important." Here, observation of growth over several months and a risk assessment of progression in the individual child can be simplified by using so-called percentile curves. Dr. Breher adds, "Whether a child has progressive myopia can be recognized, for example, by comparing values in matching growth curves with norm curves from the population. These percentiles describe the statistical distribution of values for defined age groups in a country." As soon as the length of the eye is within the range of the average, i.e. about the 50th percentile, it is seen as normal growth. However, if the eye is longer and is in the 97th percentile, for example, the child is among the 3 percent of the population in whom eye length growth may be more extreme.

Based on the current study situation – (myopia as a global trend with significant regional differences), – it is recommended to carefully look at myopia management as an additional service in Europe. At the same time, it is true that high numbers of cases are not expected to occur in Europe in the short and medium term. "Myopia management should be the best possible support for the child on the way to normal eye development, with a focus on physiologically normal length growth of the eyeball," says Dr. Christina Boeck-Maier. She works in global product management at ZEISS Vision Care on substantiating product claims, guidelines and scientific communication on myopia management. If there is an indication of an individual risk for progressive or high myopia, innovative solutions are now available for the management of this form as well. A stringent anamnesis and data recording of children at risk is essential in order to have a reliable decision basis. "Counseling should help avoid unnecessary worry," Dr. Boeck-Maier says. "On the one hand, for many myopic children, the risk of progressive myopia can be ruled out, and for affected children, innovative intervention options are available."

Spending more time outdoors supports healthy emmetropization of the eye.

For all children, the International Myopia Institute's recommendations include: spending more time outdoors to support healthy emmetropization of the eye, and limiting screen and smartphone time to two hours per day. For children identified as being at particular risk, progression monitoring that fits the intervention chosen is important. For example, intervals for follow-up differ for contact lenses and spectacle lenses.

Myopia management is successful when the growth in length of the eyeball can be slowed down to physiologically normal growth, if possible, thereby mitigating the risks for secondary eye diseases and limitations due to myopia. Myopia management will usually need to be continued until the patient is between 18 to 20 years. The detailed, scientifically based recommendations are available in the ZEISS Myopia Management Guideline.

ZEISS MyoCare lenses: Efficacy and relaxed, good vision in one lens

Various methods have been developed and tested for managing the progression of myopia, including eyeglasses, contact lenses and eye drops. ZEISS focuses on comprehensive myopia management, of which innovative spectacle lenses are an important component. ZEISS MyoCare is a new, clinically-proven, effective spectacle lens design that incorporates more than ten years of ZEISS myopia management practice, including special spectacle lenses and scientific insights into the use of contact lenses in orthokeratology.

The latest generation of myopia spectacle lenses uses microstructures to create a simultaneous competing defocus in the peripheral areas. Around the center of the lens with far distance correction, the functional zone incorporates almost invisible concentric circles with alternating defocus and correction zones expanding towards the periphery of the lens. The peripheral defocus which is achieved in this way has been shown to effectively delay the growth of the eye's length beyond that which is physiologically normal, thus slowing down the progression of myopia.

Together with a leading myopia management institute, Wenzhou Medical University Eye Hospital WMU, China, ZEISS tested different design variants. The MyoCare design, as the most promising of the tested designs, is patented as "Cylindrical Annular Refractive Elements" or C.A.R.E. Technology. To avoid hyperopic defocus for all directions of gaze, ZEISS MyoCare uses a second, innovative technology: ClearFocus optimizes the free-form back of the lens point by point.

ZEISS MyoCare is being tested together with various clinical partners in randomized clinical studies involving more than 1,000 children. The first 12-month interim results of a long-term study with Wenzhou Medical University Eye Hospital demonstrate evidence of efficacy through an absolute reduction in myopia progression in line with study expectations.

"Progressive myopia requires a particularly high sense of responsibility, because its professional management sets the course for vision as an essential prerequisite for children's development," says Dr. Ohlendorf. Research and collaboration with universities and other international scientific institutions and eye clinics will therefore continue to be an essential part of ZEISS’s efforts in making further developments in myopia management.

In parallel with the market launch of ZEISS MyoCare in Europe, the ZEISS Myopia Management Guideline on anamnesis, measurement, risk assessment, parent and child involvement, intervention, and monitoring as well as long-term care will be published. This also includes further marketing and sales materials for online and offline channels for eye care professionals, optometrists, ophthalmologists and orthoptists.
ZEISS MyoCare lenses with ZEISS coatings will be available from April 2023: ZEISS MyoCare prescription lenses with index 1.50, 1.60 and 1.67 and ZEISS UVProtect Technology for full UV protection.**

*Correction: Regarding myopia prevalence we corrected the reference year into 2050.

**Not all products are available in all markets.

Sources / remarks:

Prevalence and trends of myopia worldwide, Europe and Germany:
- Holden, B. A., Fricke, T. R., Wilson, D. A., Jong, M., Naidoo, K. S., Sankaridurg, P., Wong, T. Y., Naduvilath, T. J., & Resnikoff, S. (2016): Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology, 123(5), 1036–1042. https://doi.org/10.1016/j.ophtha.2016.01.006
- Barraza-Bernal MJ, Ohlendorf A, Sanz Diez P, Wahl S, Kratzer T. (2022, September 4-7): Myopia management need in Germany [Poster Presentation]. International Myopia Conference, Rotterdam, NL.
- Brandt M, Meigen C, Truckenbrod C, Vogel M, Poulain T, Jurkutat A, Rauscher FG, Kiess W, Wahl S.: Refraktionsstatus in einer deutschen pädiatrischen Kohorte: Eine Querschnittsanalyse der LIFE Child-Daten. Optometry & Contact Lenses. 2021;1(1):6-13. doi:10.54352/dozv.HISM2127
- Truckenbrod, C., Meigen, C., Brandt, M., Vogel, M., Sanz Diez, P., Wahl, S., Jurkutat, A., & Kiess, W. (2021): Longitudinal analysis of axial length growth in a German cohort of healthy children and adolescents. Ophthalmic and Physiological Optics, 41(3), 532–540. https://doi.org/https://doi.org/10.1111/opo.12817

Myopia development and eye health:
- Cao, K., Wan, Y., Yusufu, M., & Wang, N. (2020): Significance of Outdoor Time for Myopia Prevention: A Systematic Review and Meta-Analysis Based on Randomized Controlled Trials. Ophthalmic Research, 63(2), 97–105. https://doi.org/10.1159/000501937
- Flitcroft, D. I. (2012): The complex interactions of retinal, optical and environmental factors in myopia aetiology. Progress in Retinal and Eye Research, 31(6), 622–660. https://doi.org/10.1016/j.preteyeres.2012.06.004
- Sherwin, J. C., Reacher, M. H., Keogh, R. H., Khawaja, A. P., MacKey, D. A., & Foster, P. J. (2012): The association between time spent outdoors and myopia in children and adolescents: A systematic review and meta-analysis. Ophthalmology, 119(10), 2141–2151. https://doi.org/10.1016/j.ophtha.2012.04.020

Peripheral defocus:
- Sankaridurg, P; Donovan, L. ea: Spectacle Lenses Designed to Reduce Progression of Myopia: 12 Months Results. Optom. Vis. Sci. 2010, 87 (9), 631

Guidelines and recommendations:
- Weirich, A. (2021): Myopie-Management: Leitfaden zur Implementierung in das Geschäftsmodell eines Optometristen. Hochschule Aalen.
Gifford, K. L., Richdale, K., Kang, P., Aller, T. A., Lam, C. S., Liu, Y. M., Michaud, L., Mulder, J., Orr, J. B., Rose, K. A., Saunders, K. J., Seidel, D., Tideman, J. W. L., & Sankaridurg, P. (2019): IMI – Clinical Management Guidelines Report. Investigative Ophthalmology & Visual Science, 60(3), M184–M203. https://doi.org/10.1167/iovs.18-25977
- Truckenbrod, C., Meigen, C., Brandt, M., Vogel, M., Wahl, S., Jurkutat, A., & Kiess, W. (2020): Reference curves for refraction in a German cohort of healthy children and adolescents. PLOS ONE, 15(3), e0230291. https://doi.org/10.1371/journal.pone.0230291

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