First deferred child myopia contact lens approved by FDA

Myopia is the most common cause of visual impairment in the world, mainly caused by changes in the refractive state of the eye, the eye axis is the main factor determining refractive state, when the eye axis becomes longer, the external light can not focus on the retina at the bottom of the eye, will not see distant objects, if the occurrence of myopia, especially axial myopia, there is no way to restore the elongated eye axisTherefore, the prevention and delay of myopia is particularly importantMyopia is common in children, and children may be more likely to develop other eye conditions, such as cataracts and retinal shedding early in adulthood, if they have severe nearsightednessRecently, the World Health Organization released the first World Vision Report, which shows that there are currently 2.6 billion people nearsighted, of whom 312 million are children under the age of 19today, there are many nearsighted interventions with different effects and pros and consGlasses are commonly used for the first treatment for short-sightedness in children because they provide a clear field of vision and fewer potential side effects, and wearing contact lenses is also a treatment for children with more myopia options, which require higher sensitivity and better protection against myopia than regular glasses, but at the same time their risk is not higher than that of ordinary glassesit is understood that the contact lens, called MiSight, is a one-time soft contact lens developed by Cooper Vision, so-called disposable even if the patient should throw it away after wearing it daily, should not wear it overnightDesigned to correct myopia and delay the development of myopia in children, MiSight contact lenses can correct refractive misconduct when placed on the eye to improve long-range vision of myopia eyes, similar to standard corrective lensesIn addition, the concentric ring around the lens focuses some light on the front of the retina (the back of the eye), which is thought to reduce the irritation that causes myopia progressionMiSight's approval is based on data and evidence from prospective clinical trials in four clinical trial centers, the safety and effectiveness of which was studied in a three-year randomized controlled clinical trial of 135 children aged 8-12 who used MiSight or conventional soft contact lenses at the start of treatmentThe trial showed that people wearing MiSight lenses had less nearsightedness than those wearing traditional soft contact lenses over a three-year periodIn addition, subjects using MiSight had less change in the length of their eyeaxe shafts during each annual examinationDuring the trial, no serious eye adverse events occurred on either side of the studyin addition, to assess the incidence of vision-threatening corneal infections (i.ecorneal ulcers) in children and adolescents who wear soft contact lenses every day, the FDA conducted a retrospective analysis of the medical records of 782 children between the ages of 8 and 12, from ophthalmological clinics in seven communitiesThe results showed that the rate was comparable to that of adults who wore contact lenses every dayit is worth noting that in miSight-approved studies, manufacturers must conduct after-sales studies of contact lenses to further assess the safety and effectiveness of the products indicatedThe FDA granted Cooper Vision MiSight's approval for listing, and the device has been approved through pre-market approval (PMA)Pre-market approval is the most stringent device marketing application type required by the FDA, based on the FDA's determination that the PMA application contains sufficient valid scientific evidence to reasonably guarantee that the device is safe and effective in its intended use.