The prevalence of myopia, better known as nearsightedness, is increasing across the globe, which researchers have associated with increased time indoors looking at screens, books and other objects held close to the eyes.
Researchers hope to slow the progression of this chronic eye disease that affects approximately 40% of the U.S. population. Estimates are trending toward more than 50% of the world population having myopia.
The work to change the trend starts with children.
Lori Ann Kehler, OD, associate professor of Ophthalmology and Visual Sciences at the Vanderbilt Eye Institute (VEI), will serve as the national protocol co-chair of the Myopia Treatment Study 2, an independent, randomized, placebo-controlled trial launching in January 2026.
VEI is one of 18 pediatric eye care centers in the U.S. and the only center in Tennessee enrolling patients to determine the best way to treat myopia in children.
“This field is evolving rapidly,” said Kehler. “We know that the greatest jumps in myopia occur between ages 5 to 12, and we feel we can have the biggest impact on this age group.
“One of the reasons this research is so important — ultimately, we want to be able to prevent complications associated with myopia. If we can slow myopia earlier in life, hopefully we can reduce vision-threatening conditions later in life.”
Currently, the two most common treatments for slowing the progression of myopia in children are: low-dose atropine drops used off-label and a soft contact lens that has Food and Drug Administration approval. Neither treatment is covered by insurance.
Recently the FDA approved the use of Essilor Stellest eyeglass lenses to slow the worsening of myopia in children.
Kehler and others want to test which treatment or combination of therapies works best to slow the progression of myopia.
“While the FDA recently granted market approval for these new eyeglass lenses for myopia control, we need to do an independent study to verify their effectiveness,” said Kehler. “We also thought, what if the atropine drops and lenses can work better together?
“The data from the lens company is important, but there are so many questions. Optometrists and ophthalmologists are excited about having something to offer parents who are worried about the progression of their child’s myopia.
“The potential for these eyeglasses is significant because they are easier for children to use and can be less expensive than the other available options.”
In the upcoming trial, participants with no previous myopia control treatments and who already wear glasses will undergo an initial eye exam to determine eligibility followed by a two- to four-week artificial tears eye-drop regime to check ability to use eye drops.
The trial will use a computer program to assign patients randomly to one of the following study arms:
- Daily placebo eye drops and regular glasses
- Daily low-dose (0.05%) atropine eye drops and regular glasses
- Daily placebo eye drops and Essilor Stellest eyeglass lenses
- Daily low-dose (0.05%) atropine eye drops and Essilor Stellest eyeglass lenses
The 30-month enrollment requires clinic visits every six months. Study visits, eye drops and eyeglasses are provided at no cost.
Kehler said age-appropriate patients presenting with myopia during regular clinic visits will receive information about the trial, which is seeking 348 patients nationwide. Contact Saige Priddy at saige.priddy@vumc.org for local interest.
The study is being conducted by the Pediatric Eye Disease Investigator Group with funding provided by the National Eye Institute, part of the National Institutes of Health (grant UG1EY011751).
