As someone who had to start wearing glasses at age 9, I was excited to see a new FDA update this morning: the agency has approved the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old.
Myopia (“nearsightedness”) occurs when the eye grows too long from front to back (axial length). In a normal eye images are focused on the retina, but myopia causes the images to be focused in front of the retina. People with myopia have good near vision but poor distance vision. Past treatments included glasses and eye patches.
The MiSight soft contact lenses are worn daily to correct nearsightedness while slowing the progression of myopia. One part of the contact lens corrects the refractive error to improve distance vision, similar to a standard corrective lens. The lens also uses concentric peripheral rings to focus part of the light in front of the retina (the back of the eye), reducing the stimulus for the eye to lengthen and myopia to increase.
Myopia is the most frequent cause of correctable visual impairment worldwide. It’s common in children and tends to increase with age. If a person develops severe myopia as a child, they may be susceptible to other eye problems such as early cataracts or a detached retina during adulthood.
The safety and effectiveness of MiSight were studied in a three-year randomized, controlled clinical trial of 135 children ages 8 to 12 who used MiSight or a conventional soft contact lens. Through the full three-year period, the progression in myopia of the lens wearers was significantly less than the control group wearing conventional soft contact lenses. Subjects who used MiSight had 52% less change in the axial length of the eyeball at each annual checkup.
The lenses appear safe. No serious ocular adverse events occurred in the test or control groups. The FDA also reviewed real-world data from a retrospective analysis of medical records of 782 children ages 8 to 12 years old from seven community eye care clinics and found the same rate of corneal ulcer as that of adults who wear contact lenses daily. Corneal ulcer is irritation or damage to the cornea (surface) of the eye, often resulting from incorrect care of contact lenses.