NEI launches clinical trial testing therapies that slow childhood myopia progression

Myopia development in children.

The Pediatric Eye Disease Investigator Group (PEDIG), a research network supported by the National Eye Institute (NEI), has launched a multicenter clinical trial to evaluate whether specialized eyeglasses, atropine 0.05% eye drops, or a combination of the two can slow the progression of myopia (nearsightedness) in children.

Myopia occurs when a child's developing eyes grow too long from front to back. Instead of focusing images directly on the retina-the light-sensitive tissue in the back of the eye-the eye focuses distant images in front of the retina. As a result, distant objects appear blurry without eyeglasses.

The prevalence of myopia has increased substantially in recent decades, with projections estimating that nearly half of the world's population could be myopic by 2050. "Myopia is associated with a higher risk of serious eye diseases later in life, including retinal detachment, glaucoma, and myopic maculopathy," said one of two lead investigators, Lori Ann Kehler, OD, associate professor, Vanderbilt University Medical Center, Nashville, TN.

The randomized clinical trial, known as the Myopia Treatment Study 2 (MTS2), will enroll approximately 348 children ages 5 to younger than 12 years at clinical centers across the US. Researchers will evaluate treatment approaches over a 24-month treatment period, followed by an additional six months of observation after treatment discontinuation.

"This study will help determine whether either of two therapies alone or the combination of both provides greater protection against progressive myopia in children in the United States," said the other lead investigator, Katherine Lee, M.D., Ph.D., University of British Columbia.

Results from previously conducted studies in Asia suggest that both 0.05% atropine eye drops and specialized eyeglass with H.A.L.T. MAX technology, independently slow myopia progression. (H.A.L.T. is an acronym for Highly Aspherical Lenslet Target and does not imply a "halt" or "stop" of myopia progression.) However, these treatments have yet to be studied in a US-based pediatric population. Additionally, researchers say more evidence is needed to determine whether combining these treatments can produce greater benefits.

The study is funded by the NEI, part of the National Institutes of Health, and coordinated by the Jaeb Center for Health Research on behalf of PEDIG. Essilor International, a subsidiary of EssilorLuxottica, the manufacturer of spectacle lenses with H.A.L.T. MAX technology, is providing the eyeglasses and financial support for the study. Spectacle lenses with H.A.L.T. MAX technology have not been cleared by the US Food and Drug Administration. The 0.05% atropine eye drops used in the study are manufactured by Imprimis Rx, a subsidiary of Harrow, Inc.

The study began in June and is recruiting at 18 sites in the US. For more information, visit https://clinicaltrials.gov/study/NCT07095894

To learn more about myopia, visit the NEI information page on nearsightedness.