Efficacy of a next-generation design of ophthalmic lenses for myopia control: Six-month results of the CEME Study (133 - A0433 )

Alvarez-Peregrina, Cristina1; Sanchez-Tena, Miguel Angel1,2; Villa- Collar, Cesar3; Martinez-Perez, Clara2; Padmaja, Sankaridurg5,4; Ohlendorf, Arne5
1. Universidad Complutense de Madrid, Madrid, Spain; 2. ISEC Lisboa, Portugal; 3. Universidad Europea de Madrid, Madrid, Spain; 4. University of New South Wales, Sydney, Australia; 5. ZEISS Vision Care, Aalen, Germany.

Purpose Results The adjusted change in SE from baseline to 6 months was -0.24±0.02D
Myopia and high myopia rates are increasing worldwide.1 There have been and -0.09±0.02D with SVL and Myocare respectively (p <0.001). The
Table 1 shows the baseline characteristics of the children. There were no
numerous studies on the effectiveness of myopia control treatments in the mean adjusted difference was -0.15D, with 62.5% slower progression with
differences between the groups for baseline parameters
Asian population, but so far, studies on Caucasians have been limited.2 MyoCare than SVL. Similarly, the adjusted change in AL from baseline to
88% of the children (n=138 wearing SVL and n=130 with MyoCare) had 6 months was 0.10±0.03mm and 0.02±0.03mm with SVL and MyoCare
We aim to assess the efficacy of a new spectacle lens for myopia control
completed the 6-month visit to the date of this abstract submission. respectively (p<0.001). The mean adjusted difference was 0.07mm, with
in a European population.
76.9% slower progression with MyoCare than the SVL SPL group.
Methods: Table 1. Baseline characteristics of the sample.
In an ongoing 2-year, prospective, multicenter, stratified randomized
Baseline Characteristics Total (n = 304) MyoCare (n=152) SVL (n = 152)
clinical trial (NCT05919654), 304 Caucasian children aged between 6 and
13 were enrolled. All children were myopic with a spherical equivalent Age (Mean ± SD) 9.99 ± 1.96 10.08 ± 2.08 9.99 ± 1.85
refractive error (SE) between -0.75D and -5.00D, astigmatism ≤1.50D, Females (n, %) 174 (57.24) 87 (57.24) 87 (57.24)
anisometropia ≤1.00D, and past annual progression of at least -0.50D.
Children in the treatment group (n=152) were assigned spectacle lenses Initial cycloplegic refraction (Mean ± SD) −2.19 ± 1.05 −2.22 ± 1.05 −2.17 ± 1.05
incorporating cylinder annular refractive elements (MyoCare, ZEISS), and Initial axial length (Mean ± SD) 24.22 ± 0.74 24.26 ± 0.75 24.18 ± 0.73
those in the control group (n=152) wore single-vision lenses (SVL). Axial
Length (AL) and cycloplegic SE were measured at baseline and after 6 Figure 2 shows a detailed flowchart with the schedule of each visit.
months of wear (figure 1). Generalized linear models were constructed to
estimate the changes in SE and AL, adjusted for lens type, age, and
baseline SE or AL. The efficacy of MyoCare lenses was calculated by
dividing the difference in adjusted SE or AL change between groups by the Figure 3. Absolute changes in AL an SE after 6 months of use.
adjusted SE or AL change in the control group, then multiplying the result
by 100%.3

Figure 4. Changes in AL over the time

Conclusions
The interim analysis demonstrated that Zeiss MyoCare has been efficient
after 6 months of wear. Children will continue to be monitored after 1 and 2
Figure 1. Overview of a randomized controlled clinical trial (RCT) to assess the years of lens wear for a more comprehensive evaluation of the long-term
safety and effectiveness of CARE lenses to manage myopia progression. Figure 2. Flowchart with the schedule of assessments and examination items efficacy of the MyoCare spectacle lens in slowing the progression of myopia.

References
1. Holden BA, Fricke TR, Wilson DA, et al. Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology. 2016;123:1036–42.
2. Németh J, Tapasztó B, Aclimandos WA, et al. Update and guidance on management of myopia. ESO in cooperation with IMI. European Journal of Ophthalmology. 2021;31(3):853-883.
3. Alvarez-Peregrina, C., Sanchez-Tena, M.A., Martinez-Perez, C. et al. Clinical Evaluation of MyoCare in Europe (CEME): study protocol for a prospective, multicenter, randomized, double-blinded, and controlled clinical trial.
Trials. 2023; 24, 674.
Corresponding Author - Cristina Alvarez-Peregrina – [email protected] Disclosure Cristina Alvarez-Peregrina: Consultant: Zeiss Vision Care; Financial Support: Zeiss Vision Care, IOT, Alain Afflelou