How Safe and Effective Are Next-Generation Spectacle Lenses for Myopia Management?

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March 1, 2024

By Nabin Paudel, BOptom, PhD

Myopia is a growing public health concern that will affect an estimated 4.7 billion people by the year 2050.¹ Early intervention and management are crucial to slow its progression and reduce the risk of long-term complications.² Novel spectacle lenses have emerged as promising tools for myopia management, and several studies have reported encouraging clinical trial results. This article presents the safety and efficacy of five spectacle lenses: Hoya MiYOSMART, Essilor Stellest, Zeiss MyoCare, Rodenstock MyCon, and SightGlass Vision, based on their year three clinical trial results (if available).

Hoya MiYOSMART with Defocus Incorporated Multiple Segments Technology (DIMS)³
Utilizing the Defocus Incorporated Multiple Segments (DIMS) technology, MiYOSMART lenses induce a controlled peripheral myopic blur of +3.50D to slow axial elongation. The DIMS lens consists of a central clear zone for distance correction and honeycomb-like segments surrounding the clear zone to create peripheral blur. The results of a three-year follow-up study⁴ in 8-13-year-old Chinese children demonstrated a continued reduction of myopic progression and axial elongation among children wearing the MiYOSMART lenses compared to controls. Over three years, the cumulative spherical equivalent refraction (SER) and axial length (AL) mean changes in the DIMS group were -0.52D and 0.31 mm. The first two years of this clinical trial were an RCT. However, in the third year, DIMS wearers were compared to a historical control group. Although there are differences in the profiles of the enrolled children, the DIMS three-year findings are comparable to those in the three-year clinical trial with dual-focus myopia control contact lenses by Chamberlain et al. (-0.51D and 0.30mm).⁵  

Essilor Stellest with Highly Aspherical Lenslet Target Technology (HALT)⁶
Employing the Highly Aspherical Lenslet Target (HALT) Technology, the Stellest lenses create a volume of myopic defocus in front of the retina at any eccentricity, which theoretically acts as a myopia stop signal. To induce myopic defocus, the lens uses 1,021 contiguous aspherical lenses arranged concentrically towards the periphery. The three-year follow-up results⁷ in Chinese children aged 10-15 years showed a -1.06D reduction in myopia progression and a 0.49 mm reduction in axial elongation with good safety and tolerability. However, it must be noted that the study compared the intervention group to a newly recruited control group at year three. This is because participants from the previous two years’ control group were switched to the intervention group. 

Zeiss MyoCare with Cylindrical Annular Refractive Elements Technology (CARE)⁸
Incorporating alternating defocus and correction zones in a ring-like pattern on the front lens surface, expanding towards the periphery of the lens, the Zeiss MyoCare lens utilizes the Cylindrical Refractive Elements (CARE) Technology to create a blur effect and hence deliver a stop signal to slow the progression of axial elongation. CARE technology offers an age-specific myopia management solution, whereby the central clear zone and the mean additional surface power are 7 mm diameter and +4.60D, and 9 mm diameter and +3.80D for children <10 years and >10 years, respectively. This lens is a new addition to the field of spectacle lenses for myopia management. Hence, there is not yet any published data on its safety and efficacy. It is understood that data from a previously published study⁹ that reported the one-year results of the lens using CARE technology do not reflect the current version of the lens, as it was an earlier prototype that served as a starting point for optimization. Clinical trial results of this lens are awaited as there are several ongoing RCT trials in Europe¹⁰ and Asia. 

Rodenstock MyCon¹¹
Utilizing a perifocal design to ensure that the light in the periphery hits in front of the retina, MyCon lenses create peripheral myopic defocus at specific angles in the nasal and temporal retina along the horizontal meridian, which theoretically function as a stop signal for axial elongation. A five-year study¹² conducted in Caucasian children aged 7-14 years at time of enrollment reported an efficacy of -0.79D in the reduction of myopia progression over five years (data for individual years is not provided). The MyCon clinical study was not a randomized controlled clinical trial. 

SightGlass Vision with Diffusion Optics Technology (DOT)¹³
Aiming to address abnormal contrast signaling in the retina, the SightGlass Vision lens uses diffusers to scatter light in the peripheral retina. These diffusers are small dot-shaped elements placed across the lens periphery except in the central 5 mm aperture that provides sharp and clear vision. A three-year clinical trial study¹⁴ in Caucasian children aged 6-10 years at time of enrollment demonstrated a -0.33D reduction in myopia progression and 0.13 mm reduction in axial elongation compared to the control group. The authors note that the year two and three trial results were likely impacted due to altered school patterns of the children enrolled in the study as it coincided with the COVID-19 pandemic.

Considerations for Clinical Practice
It is important to note that direct comparisons between these lenses are challenging due to varying clinical trial methodologies, lens wearing time, and participant characteristics. While four of the five lenses discussed here demonstrated encouraging results in myopia management (clinical trial results of the MyoCare lens are not yet available), the overall efficacy differs only slightly. Key considerations for clinicians include:

• Lens design: Each lens uses a distinct design to reduce axial elongation. Therefore, the mechanism of action is different for each lens design. This could potentially impact lens tolerability and patient suitability.
• Efficacy: Reported efficacy at three years for myopia progression and axial elongation was similar between lens designs, with wear time and COVID-related disruption potentially influencing efficacy in some designs. Therefore, caution must be applied while interpreting the efficacy values. The best way to express treatment efficacy observed with myopia control is the Cumulative Absolute Reduction in axial Elongation (CARE) value and study duration, i.e., three years. Expressing efficacy as a percentage treatment effect can be misleading.
• Safety and tolerability: All lenses appear to be safe and well tolerated, with some studies reporting a slight decrease in contrast sensitivity and visual acuity when viewed through the treatment zones of the lenses.^15,16

In summary, the three-year clinical trial results provide encouraging evidence for the efficacy and safety of next-generation spectacle lenses for myopia management. However, further research is needed to compare their efficacy across ethnically diverse populations to identify optimal candidates for each technology, although some authors argue that the efficacy of myopia control intervention is independent of race.¹⁷ Additionally, despite some studies reporting long-term data,^18,19 the optimal duration of treatment remains unclear, making it challenging to determine when to stop or modify these interventions. Therefore, clinicians should consider individual patient factors such as age of onset, ethnicity, family history of myopia, level of myopia, and available evidence when selecting the most appropriate spectacle lens for each case.

 

Dr. Nabin Paudel is a vision scientist currently working at Retina International in Dublin, Ireland. Prior to this, his role was a postdoctoral scientist at the Centre for Eye Research Ireland, where he was involved in conducting several clinical trials for myopia control. Dr. Paudel completed his PhD in pediatric visual development from the University of Auckland, New Zealand, in 2016. Dr. Paudel’s areas of particular interest include myopia, retina, philanthropy, science communication, mentoring, as well as patient and public involvement in research.

 

References

1. Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology. 2016 May 1;123(5):1036-42.
2. Bullimore MA, Brennan NA. Myopia control: why each diopter matters. Optometry and Vision Science. 2019 Jun 1;96(6):463-5.
3. Lam CS, Tang WC, Tse DY, Lee RP, Chun RK, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. British Journal of Ophthalmology. 2020 Mar 1;104(3):363-8.
4. Lam CS, Tang WC, Lee PH, Zhang HY, Qi H, Hasegawa K, To CH. 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. 2021 Mar 17.
5. Chamberlain, P., Peixoto-de-Matos, S. C., Logan, N. S., Ngo, C., Jones, D., & Young, G. (2019). A 3-year randomized clinical trial of MiSight lenses for myopia control. Optometry and Vision Science, 96(8), 556-567.
6. Bao, J., Yang, A., Huang, Y., Li, X., Pan, Y., Ding, C., … & Chen, H. (2022). One-year myopia control efficacy of spectacle lenses with aspherical lenslets. British Journal of Ophthalmology, 106(8), 1171-1176.
7. Li, X., Huang, Y., Yin, Z., Liu, C., Zhang, S., Yang, A., … & Bao, J. (2023). Myopia control efficacy of spectacle lenses with aspherical lenslets: results of a 3-year follow-up study. American Journal of Ophthalmology, 253, 160-168.
8. https://www.zeiss.ie/vision-care/eye-care-professionals/lenses/lenses-for-every-need/lenses-to-manage-myopia-progression-in-children.html 
9. Liu X, Wang P, Xie Z, Sun M, Chen M, Wang J, Huang J, Chen S, Chen Z, Wang Y, Li Y, Qu J, Mao X. One-year myopia control efficacy of cylindrical annular refractive element spectacle lenses. Acta Ophthalmol. 2023 Sep;101(6):651-657.
10. Alvarez-Peregrina C, Sanchez-Tena MA, Martinez-Perez C, Villa-Collar C; Clinical Evaluation of MyoCare in Europe –the CEME Study Group; Ohlendorf A. Clinical Evaluation of MyoCare in Europe (CEME): study protocol for a prospective, multicenter, randomized, double-blinded, and controlled clinical trial. Trials. 2023 Oct 17;24(1):674.
11. https://www.rodenstock.com/uk/en/childrens-spectacles.html 
12. Tarutta EP, Proskurina OV, Tarasova NA, Milash SV, Markosyan GA. Long-term results of perifocal defocus spectacle lens correction in children with progressive myopia. Vestn. Oftalmol. 2019 Jan 1;135:46-53.
13. Rappon, J., Chung, C., Young, G., Hunt, C., Neitz, J., Neitz, M., & Chalberg, T. (2022). Control of myopia using diffusion optics spectacle lenses: 12-month results of a randomised controlled, efficacy and safety study (CYPRESS). British Journal of Ophthalmology.
14. Chalberg, T., Laughton, D., Hill, J., Tasso, V., Young, G., Hunt, C., … & Neitz, M. (2023). Control of Myopia Using Diffusion Optics Spectacle Lenses: Efficacy and Safety Study (CYPRESS) 42-month results. Investigative Ophthalmology & Visual Science, 64(8), 5092-5092.
15. Lu Y, Lin Z, Wen L, Gao W, Pan L, Li X, Yang Z, Lan W. The adaptation and acceptance of defocus incorporated multiple segment lens for Chinese children. American journal of ophthalmology. 2020 Mar 1;211:207-16.
16. Li X, Ding C, Li Y, Lim EW, Gao Y, Fermigier B, Yang A, Chen H, Bao J. Influence of lenslet configuration on short-term visual performance in myopia control spectacle lenses. Frontiers in Neuroscience. 2021 May 25;15:667329.
17. Bullimore, M. A., & Brennan, N. A. (2023). Efficacy in Myopia control: Does race matter?. Optometry and Vision Science, 100(1), 5-8.
18. Drobe, B., Xue, L., Huang, Y., Lim, E. W., & Bao, J. (2023). Spectacle lenses with highly aspherical lenslets for myopia control: 4-year clinical trial results. Investigative Ophthalmology & Visual Science, 64(8), 4162-4162.
19. Lam CS, Tang WC, Zhang HY, Lee PH, Tse DY, Qi H, Vlasak N, To CH. Long-term myopia control effect and safety in children wearing DIMS spectacle lenses for 6 years. Scientific Reports. 2023 Apr 4;13(1):5475.