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A newly approved contact lens from CooperVision promises to slow the progression of nearsightedness when prescribed to children aged 8 to 12.
Source: CooperVision
The US Food and Drug Administration has approved the first contact lens that can help slow the progression of nearsightedness (myopia) in children.
The agency announced the PMA approval of CooperVision Inc.’s MiSight contact lens on 15 November. The daily-wear disposable soft contact lens is intended for use in children aged 8 to 12.
Myopia is the most common correctible vision problem and occurs when the eye grows too long from front to back. This causes images to focus on a point in front of the retina, which leads to poor distance vision that can be corrected with contact lenses or glasses. Typically diagnosed in childhood, the condition usually worsens with age. Myopia may lead to more severe eye problems such as cataracts, glaucoma or detached retinas in adulthood.
About 41.9% of US schoolchildren are nearsighted, CooperVision says. Some data suggests the rate has been increasing in recent years due to an increase in screen time and other close work.
In addition to a standard corrective lens, the MiSight also incorporates concentric peripheral rings in the lens that focus part of the light in front of the retina. This is believed to help slow the progression of myopia by reducing stimulus, the FDA says.
The approval was based on a four-site randomized clinical trial that followed 135 children aged 8 to 12 for three years. Over the course of the study, children who used MiSight had less worsening of myopia and smaller changes in the axial length of the eyeball than a control group that used standard soft contact lenses. No serious adverse events occurred in either arm of the study.
Additionally, a review of medical records for 782 children seen at community eye-care clinics found that children who wear soft contact lenses suffer vision-threatening corneal infections at a similar rate to adults, further bolstering the safety profile of the lens.
“We can’t overstate the importance and potential impact of this landmark decision on children’s vision, especially considering the rise in myopia’s severity and prevalence in the US and worldwide. Eye-care professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children,” CooperVision president Daniel McBride said in a statement.
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