Good news for nearsighted children! FDA approved the first contact lens to delay the development of myopia in children

On November 16, the FDA announced the approval of the first contact lens for delaying the development of myopia in children aged 8-12 The contact lens, called misight, is a disposable soft contact lens developed by Cooper vision Patients should discard it after wearing it every day and should not wear it overnight Myopia is due to the long axis of the eye growth is too long, resulting in the image can not focus on the retina, but focus in front of the retina This causes the patient to have no vision problems when looking close, but they need to wear glasses or contact lenses when looking far away Myopia is very common in children If children have severe myopia, they are more likely to suffer from other eye diseases, such as cataract and retinal detachment earlier in adulthood Misight contact lenses are designed to correct myopia and delay its development by wearing them daily When worn on the eyes, the concentric circles in the contact lenses focus part of the light in front of the retina, in addition to correcting the vision like ordinary glasses This is believed to reduce the stimulant factors that contribute to the progression of myopia ▲ treatment mechanism of misight contact lenses (photo source: Cooper vision official website) Mishight's approval is based on a prospective clinical trial and real world evidence Its safety and effectiveness were verified in a randomized, controlled clinical trial involving 135 children aged 8-12 years The results showed that after the three-year trial, the myopia progress of children wearing misight contact lenses was less than that of children wearing traditional contact lenses And at the annual eye examination, the length of the eye axis of children wearing misight changed less In addition, according to the real world data, the FDA analyzed the corneal infection rate of 782 children aged 8-12 years who may be affected by contact lenses The study found that children wearing contact lenses have the same risk of corneal infection as adults The FDA uses the premarket approval pathway (PMA) to approve misight's application This means that FDA believes that PMA application contains enough scientific evidence to prove the safety and efficacy of medical devices As part of misight's approval, Cooper vision needs to conduct a post market study to further assess the safety and effectiveness of this contact lens "Today's approval is the first FDA approved product to slow the development of myopia in children, which may ultimately reduce the risk of other eye diseases." Dr Malvina eydelman, director of the FDA Center for equipment and radiology, office of Ophthalmology, anesthesiology, respiratory, otolaryngology and dental devices reference material: [1] FDA approves first contact lens indicated to slow the progression of nearsightedness in children Retrieved November 15, 2019, from https:// A kind of