CARE spectacle lenses slow myopia over 2 years

Paper title: Efficacy of Cylindrical Annular Refractive Elements (CARE) Spectacle Lenses in Slowing Myopia Progression Over 2 Years

Authors: Chen X (1,6), Wu M (2), Yu C (3), Ohlendorf A (4), Li W (5), Liu N (4), Yang Y (5), Li L (1,6), Sankaridurg P (7)

1. Tianjin Eye Hospital, Tianjin Key Lab of Ophthalmology and Visual Science, Tianjin, PR China
2. Beijing Tongren Vision Care, Beijing Tongren Hospital, Capital Medical University, Beijing, PR China
3. He Eye Specialist Hospital, Shenyang, Liaoning Province, PR China
4. ZEISS Vision Care, Aalen, Germany
5. ZEISS Vision Care, Carl Zeiss Vision (Guangzhou) Ltd., Guangzhou, PR China
6. Tianjin Eye Hospital Optometric Center, Tianjin, PR China
7. ZEISS Vision Care, Aalen, Germany; School of Optometry and Vision Science, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia

Date: Published October 2025.

Reference: Chen X, Wu M, Yu C, Ohlendorf A, Li W, Liu N, Yang Y, Li L, Sankaridurg P. Efficacy of Cylindrical Annular Refractive Elements (CARE) Spectacle Lenses in Slowing Myopia Progression Over 2 Years. Am J Ophthalmol. 2025 Oct; 278:203-211.

[Link to open access paper]

Many current spectacle-based optical strategies for slowing myopia progression have employed relative positive power across specific areas of the lens to induce myopic defocus or have incorporated light-scattering elements to provide contrast modulation at the retina. Cylindrical Annular Refractive Elements (CARE) lenses use a configuration of concentric micro-cylinder arrays placed around a central clear zone which provides the refractive correction. A prior one-year trial demonstrated that both CARE and CARE S lenses slowed myopia progression in children, compared to single vision lenses. This ongoing randomised clinical trial reports on the efficacy of CARE and CARE S lenses beyond 12 months to two years.

Chinese children aged 6 to 13 years with baseline myopia from –0.75 D to –5.00 D were randomly allocated into three groups wearing CARE lenses (7 mm clear zone with +4.6 D mean treatment power), or CARE S lenses (9 mm clear zone with +3.8 D mean power), or single vision (SV) lenses. Cycloplegic spherical equivalent (SE) and axial length (AL) were measured at 6-month intervals over 2 years. 

Key findings were as follows.

• Mean 2-year myopia progression was –0.73 D, –0.80 D and -1.15D for CARE, CARE S and SV, respectively, giving a treatment effect of 0.44 D (37%) and 0.41 D (30%).
• Axial elongation was 0.40 mm, 0.44 mm and 0.59 mm for CARE, CARE S and SV, respectively, giving 0.20 mm (32%) and 0.17 mm (25%) less elongation over two years.
• There was no clinically meaningful difference in outcomes between CARE and CARE S designs
• Treatment effect was sustained through the second year, though the effect was slightly reduced compared to year one.
• A progression of 1.25D or more was avoided by 75% of eyes in the CARE group and 71% in CARE S, compared with 50% in the SV group.
• Children who wore CARE lenses for more than 14 hours per day (i.e., all waking hours) had significantly lower progression (-0.63D / 53% and 0.23mm / 40%) than those with shorter wear time. 

This study provides the first two-year data on the use of CARE spectacle lenses. While most of the treatment effect occurred in the first year, smaller but statistically significant gains were still achieved in the second year. This suggests that even if greater effects are seen in the first year of use, continued wear is still beneficial compared to single vision lenses. 

Children who wore CARE lenses for longer each day (14+ hours, or all waking hours) experienced greater treatment effect, suggesting there may be a dose-dependent relationship. Compliance with full-time wear should be advised to optimise outcomes.

The study found that although the treatment effects of both CARE and CARE S lenses continued into the second year, they were reduced compared to the first year. This observation aligns with previous analysis of efficacy data which found that myopia control effects are typically higher in the first year of treatment and suggested further research is needed to establish why efficacy appears to slow over time.

The CARE lens demonstrated slowing of SE progression in the second year, whereas the CARE S lens did not. Further studies are needed to establish if the smaller central zone or higher treatment power in the CARE lens design was a contributing factor. There was also a small difference between CARE and CARE S performance with wear times of >14 hours per day. However, compliance with wear times was self-reported, which may introduce recall bias. Objective monitoring of wear time in future studies could inform on wear-time dependent outcomes.

A sub-analysis of the participants who withdrew from the study found they had greater myopia progression than those who continued the trial. Consequently, fewer faster progressors in the control group may mean the treatment effect was under-estimated.

Purpose: To evaluate over a 2-year period the efficacy of spectacle lenses incorporating cylindrical annular refractive elements (CARE) in slowing myopia progression compared with single vision (SV) spectacle wear.

Design: Double-masked, multicenter, randomized clinical trial.

Methods: A total of 240 Chinese children aged 6 to 13 years, with a spherical equivalent (SE) refractive error of -0.75 diopters (D) to -5.00 D, were randomized to 1 of 3 groups of SV spectacle lens: CARE spectacles (7-mm central clear zone surrounded by treatment zone incorporating CARE with mean surface power +4.6 D) and CARE S spectacles (9-mm central clear zone surrounded by treatment zone comprising CARE with mean surface power +3.8 D). Cycloplegic SE and axial length (AL) were measured at 6-month intervals.

Results: Progression (mean ± SD) in SV-wearing eyes after 24 months of SPL wear was -1.15 ± 0.63 D and 0.59 ± 0.26 mm with SV for SE and AL, respectively. In comparison, myopia progression was significantly slower with both CARE (-0.73 ± 0.63 D / 0.40 ± 0.26 mm, P < .0001) and CARE S (-0.80 ± 0.56 D / 0.44 ± 0.25 mm, P < .0001). Progression did not differ significantly between CARE lenses. Adjusting for site, group, age, gender, and baseline value at 24 months, CARE showed an absolute difference in SE of 0.44 D (95% CI, 0.21–0.66 D) and CARE S 0.41 D (95% CI, 0.18–0.63 D) compared with SV. AL reduction was 0.20 mm (95% CI, 0.10–0.30 mm) with CARE and 0.17 mm (0.07–0.26 mm) with CARE S compared with SV.

Conclusions: Over a 2-year period, lenses incorporating CARE significantly slowed myopia progression compared with SV lenses.

[Link to open access paper]