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Evaluating the Effect of a Myopia Control Spectacle Lens Among Children in Israel: 12-Month Results
Cohen Yuval1, Chassid Otzem1, Benhaim-Sitbon Laura2
1From the Department of Ophthalmology, Ziv Medical Center (C.Y., C.O.), Safed; Azrieli Faculty of Medicine, Bar-Ilan University (C.Y., C.O.), Safed.
Insights
Novel Shamir Myopia Control (SMC) spectacle lenses effectively slowed myopia progression in children. These lenses showed particular benefit for younger children and those with two myopic parents, with good tolerability.
Area of Science:
- Ophthalmology
- Pediatric Optometry
- Myopia Management
Background:
- Myopia, or nearsightedness, is a growing public health concern in children.
- Effective myopia control strategies are crucial to prevent high myopia and associated ocular complications.
- Novel spectacle lens designs offer a promising avenue for myopia management.
Purpose of the Study:
- To evaluate the efficacy of a new spectacle lens design, Shamir Myopia Control (SMC), in slowing myopia progression in children.
- To compare the effectiveness of SMC lenses against conventional single-vision lenses (SVL).
Main Methods:
- A prospective, randomized, double-blind clinical trial involving 126 children aged 6-13 years.
- Participants had spherical equivalent (SER) refractive errors between -0.5 D and -6.25 D.
- Outcomes included changes in axial length (AL) and cycloplegic refraction (SER) over 12 months, with subjective visual experience also assessed.
Main Results:
- SMC lenses slowed AL progression by 35% (0.11 mm) and SER progression by 25% (0.16 D) at 12 months.
- Significant slowing of AL and SER progression was observed in younger children (6-10 years) and those with two myopic parents.
- No significant differences in subjective visual experience or daily wearing hours were reported between SMC and SVL groups.
Conclusions:
- Shamir Myopia Control (SMC) lenses demonstrated effectiveness in reducing myopia progression, particularly in specific pediatric subgroups.
- The study indicates good tolerability and acceptance of SMC lenses, comparable to conventional lenses.
- Further investigation into the long-term effects of SMC lenses is warranted as the study continues.
Purpose:
To investigate the effectiveness of a novel spectacle lens designed to slow the progression of myopia in children.
Design:
A prospective, randomized, double blind clinical trial.
Methods:
One hundred twenty-six Israeli children aged 6-13 years with spherical equivalent (SER) refractive errors of -0.5 to -6.25 diopters (D) were randomized into either the Shamir Myopia Control (SMC) lens design group or the conventional single-vision spectacle lenses (SVL), the control group. Outcomes measured were changes in axial length and cycloplegic refraction as well as subjective rating of visual experience over a period of 12 months.
Results:
At 12 months, AL and SER progression were slowed by 0.11 mm (35%, P < .05) and 0.16 D (25%, P = .122), respectively. In the subgroup of 6-10-year-olds, AL and SER progression were slowed by 0.17 mm (41%, P < .05) and 0.31 D (43%, P < .05), respectively. Similarly, for the subgroup of children with 2 myopic parents AL and SER progression were slowed by 0.15 mm (45% P < .05) and 0.36 D (42%, P < .05), respectively. Subjective visual experience reported in the 12-month questionnaire revealed no difference between the SMC and SVL groups, and average daily wearing hours were also not different between the groups: 14 (±1.4) and 13.8 (±2.3) hours, respectively. The study continues to its second year.
Conclusions:
SMC lenses were effective in slowing the progression of SER and AL, especially for younger children and those having 2 myopic parents. The subjective rating of visual experience and the daily duration of use reported by the SMC group at 12 months were similar to the control group, indicating good lens tolerability.
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