In late September the U.S. Food and Drug Administration made an announcement that has the potential to positively impact tens of millions of kids for the rest of their lives.
That’s because the FDA authorized the marketing of a new eyeglass lens to correct myopia, commonly known as nearsightedness. The lens addresses myopia with or without astigmatism — and, more importantly, also slows the progression of the condition in children who are ages 6 to 16 at the time of their initial diagnosis.
“As a practicing ophthalmologist, I see firsthand the lifelong impact that vision problems can have on an individual,” said Center for Devices and Radiological Health Director Dr. Michelle Tarver in a statement released by the FDA. “This authorization brings to market a treatment option that may meaningfully reduce the likelihood of severe eyesight issues later in adult life, while also being easier to use and lower risk than the currently authorized devices that slow the progression of myopia in children.”
The lens is made by the Paris, France-based company Essilor and is known as the Essilor Stellest eyeglass lens. Prior to the Stellest there was only one FDA-approved device for slowing the progression of myopia and it came in in the form of contact lenses for children who were ages 8 to 12.
Limited treatments for myopia in children
“This lens technology evolves the traditional corrective lenses into a true medical treatment, and it marks the beginning of a new era for eyecare professionals in addressing myopia,” said Francesco Milleri, chairman and CEO of parent company EssilorLuxottica, in a written statement. “We are thrilled to have been granted FDA’s market authorization for Essilor Stellest in the U.S., bringing it to young patients in need. This groundbreaking innovation is a major milestone on our mission to empower people and allow them to greater control their health.”
According to both Essilor and the FDA, the Stellest lenses, when worn 12 hours daily, slow the progression of myopia by an average of 67% as compared to other single-vision lenses. After two years of usage, there was a 71% slowdown in myopia progression.
The FDA noted that “the Essilor Stellest eyeglass lenses can fill the gap for children 6 to 7 years old or for children who are unable to wear contacts. Essilor Stellest eyeglass lenses are a lower risk device compared to contact lenses and do not have adverse events (such as infections) that may be associated with the use of contact lenses.”
Prior to Essilor Stellest eyeglass lenses, there was only one FDA-approved device for slowing the progression of myopia and it came in in the form of contact lenses for children who were between ages 8 and 12. The Stellest lenses are approved for those aged 6 and older.
How the lenses work
The FDA explained that the Essilor Stellest eyeglass lenses have a clear 9mm diameter area in the center, which is surrounded by rings of tiny, raised dots (peripheral lenslets) on the rest of the lens. The tiny, raised dots provide peripheral light defocus, which may help to slow the progression of myopia in children.
The National Institutes of Health says myopia occurs when the eye grows too long, and the image projected on the retina is poorly focused when a person is trying to view an image at a distance. According to CNN “when a child first becomes nearsighted is when their vision is changing the fastest and their eye is growing most rapidly.”
Ohio State University professor of optometry Dr. Jeff Walline told CNN that “we know from longitudinal studies that a child’s myopia is progressing the fastest when you first see that they become nearsighted” and that’s why he urges parents to treat their child’s condition at the first indication that their vision has become compromised.
Essilor explained that its Stellest lens incorporates a technology it calls HALT (Highly Aspherical Lenslet Target).
The company says that the HALT technology is comprised of “a constellation of 1,021 invisible lenslets. This constellation creates a signal in front of the retina that acts as a shield against eye elongation and, therefore, myopia progression.”
Essilor’s clinical testing also showed that, after two years of usage, eye elongation — which, remember, is the cause of myopia — was decreased by 53%.
The FDA noted that “there were no serious adverse events reported in the clinical study. However, some subjects did report visual symptoms, such as blur and halos.”
Essilor’s Stellest lens incorporates a technology it calls HALT (Highly Aspherical Lenslet Target) that is comprised of “a constellation of 1,021 invisible lenslets. This constellation creates a signal in front of the retina that acts as a shield against eye elongation and, therefore, myopia progression.”
Increasing prevalence of myopia
The National Eye Institute notes that several studies indicate that the prevalence of myopia is increasing in the U.S. and worldwide, and researchers project the trend will continue in the coming decades.
The condition currently affects approximately 40% of the U.S. population, with the prevalence increasing rapidly among children and adolescents.
The National Eye Institute estimated that, by 2050, more than 50% of the world’s population may become myopic.
When left untreated, or undertreated (meaning that the patient’s vision correction prescription isn’t updated), the condition can progress to “high myopia” — a disease that significantly increases the risk for sight-threatening complications, including retinal detachment, myopic maculopathy, glaucoma, and cataracts later in life.
Steve Dorfman is a journalist for The Palm Beach Post, part of the USA Today Network of Florida. He writes about all aspects of health, fitness and wellness. If you have news tips, please send them to [email protected]. Help support our local journalism, subscribe today.
This article originally appeared on Palm Beach Post: New Stellest eyeglass lenses slow progression of myopia in kids
