Saturday, December 14, 2019

Contact Lens That Helps Children with Nearsightedness Gets FDA Approval

  • A contact lens that helps children with nearsightedness (myopia) in Australia, Canada, and other countries has been approved for use in the United States.
  • Experts say the contact lens will ease the progression of myopia in children between 8 and 12 years old.
  • That should help reduce the risk of long-term eye problems, such as retinal detachment and glaucoma.

Help is on the way for young children who have nearsightedness.

The Food and Drug Administration (FDA) has approvedTrusted Source the first contact lens designed to slow the progression of myopia in children between 8 and 12 years old.

The MiSight contact lens is a soft, single use, disposable lens that’s discarded at the end of each day without overnight use.

“This is a big deal, because we hope this will finally put myopia control management in the spotlight,” Dan Press, OD, FCOVD, an optometrist at Park Ridge Vision in Illinois, told Healthline.

“There is a mountain of evidence supporting multiple options to slow the progression of childhood myopia, but the uptake has been slow since none of the treatments were FDA approved to specifically slow down myopia. Our hope is that this brings the discussion into the mainstream, and doctors that have not been on board in the past will get on board now,” he said.

According to the FDA, myopia is the most frequent cause of correctable visual impairment across the world.

Myopia happens when the eye grows too long from front to back. Instead of focusing images on the retina, images are focused on a point in front of the retina.

People with myopia frequently have what’s considered good vision, but they struggle with poor distance vision that usually must be addressed with glasses or contact lenses.

“Myopia first occurs in primary and elementary-age children and progresses until about age 20,” Dr. Rupa K. Wong, a pediatric ophthalmologist based in Honolulu, told Healthline.

“In childhood, uncorrected myopia may impair children’s ability to fully participate in everyday activities, such as school, extracurriculars like sports, dance, and music,” she said.

Long-term problems

Myopia isn’t just about improving a child’s performance or limiting vision-related injuries on a field.

There’s a real question of health. And the sooner it’s dealt with, the better.

“The prevalence and severity of myopia are increasing, especially in our current reading device–focused culture,” Wong said. “There’s widespread acknowledgement that progression can be managed, but there needs to be more urgency to act earlier.”

As if myopia alone isn’t enough to deal with, research shows it can lead to other eye problems later in life.

“Evidence has demonstrated that higher levels of myopia are associated with increased risk of retinal detachment, cataracts, glaucoma, and other vision-threatening issues later in life,” Wong said.

She says not only can the new contact lens address the sight problems, it can also affect the elongation of the eye.

“Individuals who are nearsighted typically have a longer eyeball than those who are not. Their higher axial length means that their retina gets stretched more compared to people who are not myopic. It could mean that these kids will be much less at risk for the development of retinal detachments, retinal tears, or even cataracts, as adults,” Wong explained.

Studying the new contact lens

The approval of MiSight was based on data gathered from four clinical sites, according to the FDA.

Its safety and effectiveness were studied in a 3-year, randomized controlled clinical trial of 135 children, ages 8 to 12 years, who used MiSight or a conventional soft contact lens.

The trial showed that for the first 3-year period, progression of myopia in those using MiSight was less than those wearing conventional lenses.

MiSight participants also had less change in the axial length of the eyeball at each annual checkup. There were no serious ocular adverse events reported during the study.

Though those trials were done for use in the United States, there’s also plenty of anecdotal evidence from around the world, where MiSight has already been in use for a significant amount of time.

“This is terrific news for our eye care practitioner colleagues in the United States,” Damon Ezekiel, B Optom, FAAO, FCLSA, an Australian optometrist and the president of the International Society of Contact Lens Specialists, told Healthline.

“We are very fortunate that we in Australia have had access to the MiSight lens, along with Canada, United Kingdom, and Spain. This brings the United States in line with so many countries.

“Personally, I have quite a number wearing MiSight. All of our patients who have been wearing the MiSight lenses are very happy. Their visual acuities are stable, and they love the convenience of wearing a daily disposable lens,” Ezekiel said.

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