This contact lens, called misight, is a disposable soft contact lens developed by Cooper vision, which means that patients should discard it every day after wearing it, and should not wear it overnight. It is specially designed for correcting myopia and delaying the development of myopia in children. When it is placed on the eyes, misight contact lenses can correct ametropia, so as to improve the long-distance vision of myopia, similar to standard corrective lenses.

 

 

 

In addition, concentric rings around the lens focus part of the light in front of the retina (the back of the eye), which is thought to reduce the stimulation that causes myopia to progress.

 

 

 

Misight's approval was based on data and evidence from prospective clinical trials conducted in four clinical trials centers. The safety and efficacy of misight was studied in a three-year randomized controlled clinical trial in which 135 children aged 8-12 years were enrolled in misight or conventional soft contact lenses.

 

 

 

The trial showed that during the entire three years, people wearing misight lenses had less progress in myopia than those wearing traditional soft contact lenses. In addition, subjects using misight had a smaller change in the length of the eyeball axis at each annual examination. During the trial, no serious ocular adverse events occurred in either party of the study.

 

 

 

In the research approved by misight, the manufacturer must conduct after-sales research on contact lenses to further evaluate the safety and effectiveness of the indicated products . The FDA has granted the listing approval of misight to Cooper vision, and the device has been approved through the pre listing approval (PMA) channel.

 

 

 

Pre market approval is the most stringent type of equipment marketing application required by FDA, which is based on FDA's determination that PMA application contains sufficient effective scientific evidence to reasonably ensure the safety and effectiveness of the equipment in its intended use.