November 15, 2022
By Dwight Akerman, OD, MBA, FAAO, FBCLA, FIACLE
Optical interventions that introduce myopic defocus in the visual field have been utilized for myopia progression control. These include a variety of simultaneous vision soft contact lenses, such as aspheric progressive, dual-focus, traditional multifocal, and extended depth of focus designs. These optical designs can introduce aberrations to the eye, affecting vision. Aiming to develop a method for myopia progression control that preserves visual performance, researchers from Johnson & Johnson Vision investigated soft contact lens prototypes featuring a novel ring-focus design.*
The researchers evaluated efficacy and vision with two prototype myopia control soft contact lenses with non-coaxial ring-focus designs (EE, for enhancing efficacy, and EV, for enhancing vision) compared to dual-focus (DF) and single-vision (SV) designs.
EE was designed to increase myopia control efficacy by introducing a greater amount of plus power than conventional multifocal or dual-focus lens designs while maintaining comparable visual performance. EV was designed to optimize vision while maintaining similar myopia control efficacy to a standard dual-focus lens. Both lenses included two concentric, annular zones with +7D non-coaxial plus power for myopia control treatment, but these annular treatment zones in the EE lens were positioned closer to the center of the lens than for EV. EE also includes a +10D co-axial treatment zone that was designed to further “boost” myopia control efficacy while limiting its impact on vision. These lens prototypes were granted “Breakthrough Device” designation by the United States Food and Drug Administration.
A total of 185 subjects completed the study (n = 44, 49, 45, and 47, for EE, EV, DF, and SV, respectively). There were no serious/significant ocular adverse events. After 26 weeks, EE, EV, and DF all had statistically significantly less axial elongation compared to SV (unadjusted mean [SD]: EE, 0.079 [0.125]; EV, 0.119 [0.101]; DF, 0.135 [0.117]; SV; 0.189 [0.121] mm). The estimated least-square mean (LSM) difference (adjusted 95% CI) compared to SV were -0.105 (-0.149, -0.062), -0.063 (-0.106, -0.020), and -0.056 (-0.100, -0.013) mm for EE, EV, and DF, respectively. EE alone had statistically significantly less progression of SECAR than SV (EE: -0.12 [0.27] D vs. SV: -0.35 [0.33] D; LSM difference: 0.22 D [0.09, 0.35]). EE also had statistically significantly less axial elongation compared to DF (-0.049 mm [-0.093, -0.004]). Changes in AL and SECAR of EV and DF were not statistically different. All three myopia control lenses had mean VA close to 0.00 logMAR with an estimated 95% CIs less than 0.10 logMAR. EE and DF produced similar reports of haloes but more than EV and SV.
The researchers concluded that the efficacy and vision performance of the EE and EV lens met the design intent, demonstrating that non-coaxial ring-focus technology offers an alternative approach with the potential to mitigate some of the limitations of conventional presbyopic co-axial principles. They consider EE a viable soft contact lens candidate for further investigation of myopia control in children.
* Johnson & Johnson Vision launched the ACUVUE Abiliti 1-Day Soft Therapeutic Lens for Myopia Management in Canada in 2021. ACUVUE Abiliti 1-Day Soft Therapeutic Lens for Myopia Management is not available and not approved in the United States.
Abstract
Randomized Trial of Soft Contact Lenses with Novel Ring Focus for Controlling Myopia Progression
Xu Cheng, MD, PhD, Jie Xu, PhD, Noel A. Brennan, MScOptom, PhD
Purpose: To evaluate efficacy and vision with two prototype myopia control soft contact lenses with non-coaxial ring-focus designs (EE, for enhancing efficacy, and EV, for enhancing vision) compared to dual-focus (DF) and single-vision (SV) designs.
Design: Multi-center, 6-month, randomized, controlled, double-masked clinical trial.
Participants: 199 myopic (-0.75D to -4.50D) children aged 7 to 12 years.
Methods: Participants were randomized with stratification into myopia control (EE, EV, or DF) or SV arms at 9 clinical sites in 3 countries. Post-cycloplegia axial length (AL) and spherical equivalent autorefraction (SECAR) were measured at baseline and 26 weeks. AL was also measured without cycloplegia at baseline, 1, 4, 13, and 26 weeks. Progression was analyzed using linear mixed models by intention-to-treat population. Visual acuity (VA) and vision quality were monitored.
Main Outcome Measures: Axial elongation, change in SECAR.
Results: A total of 185 subjects completed the study (n = 44, 49, 45, and 47, for EE, EV, DF, and SV, respectively). There were no serious/significant ocular adverse events. After 26 weeks, EE, EV, and DF all had statistically significantly less axial elongation compared to SV (unadjusted mean [SD]: EE, 0.079 [0.125]; EV, 0.119 [0.101]; DF, 0.135 [0.117]; SV; 0.189 [0.121] mm). The estimated least-square mean (LSM) difference (adjusted 95% CI) compared to SV were -0.105 (-0.149, -0.062), -0.063 (-0.106, -0.020), and -0.056 (-0.100, -0.013) mm for EE, EV, and DF, respectively. EE alone had statistically significantly less progression of SECAR than SV (EE: -0.12 [0.27] D vs. SV: -0.35 [0.33] D; LSM difference: 0.22 D [0.09, 0.35]). EE also had statistically significantly less axial elongation compared to DF (-0.049 mm [-0.093, -0.004]). Changes in AL and SECAR of EV and DF were not statistically different. All three myopia control lenses had mean VA close to 0.00 logMAR with an estimated 95% CIs less than 0.10 logMAR. EE and DF produced similar reports of haloes but more than EV and SV.
Conclusions: The prototype contact lenses met the design intent; EE was more efficacious in slowing axial elongation than DF with comparable vision performance, while EV produced comparable efficacy to DF with similar vision performance to SV.
Cheng, X., Xu, J., & Brennan, N. A. (2022). Randomized trial of soft contact lenses with novel ring focus for controlling myopia progression. Ophthalmology Science, 100232. October 18, 2022. [Epub ahead of print].
DOI:https://doi.org/10.1016/j.xops.2022.100232
