A low dose of atropine, a drug used to dilate pupils, shows promise in slowing the progression of nearsightedness in children, a new study finds.
An estimated 9.6 million adults in the United States are highly myopic or, severely nearsighted. The number of people with this life-long condition grew from about 25% in the early 1970s to 40% in 2004, whereas the global prevalence of myopia is predicted to increase to 50% by 2050.
Myopia usually starts in childhood, between six and 13 years of age. Besides causing the daily inconvenience of having to wear glasses or lenses, myopia can also lead to severe complications, such as cataracts or glaucoma. Nevertheless, no pharmacological treatment in the U.S. is available to slow myopia progression thus far.
The researchers at the Ohio State University examined whether atropine, a drug used to dilate pupils, is safe and more effective than a placebo at limiting eyeglass prescription changes and inhibiting elongation of the eye, which causes myopia, in nearsighted children aged six to 10. The findings were published in the journal JAMA Ophthalmology.
The trial included 489 children who were randomized into groups receiving eye drops consisting of 0.01% or 0.02% of atropine or a placebo for three years. They were given one daily drop per eye at bedtime to minimize the disruption of any blurring effects atropine might have on vision.
Researchers looked at the proportion of participants’ eyes responding to therapy, defined as <0.50 D myopia progression at three years, as well as changes in spherical equivalent refraction and axial length, both of which are measurements for myopia. The most significant improvements at all time points compared to placebo resulted from the solution containing 0.01% of atropine. The 0.02% atropine formulation had a significant effect compared to placebo only at month 12.
"The 0.01% story is clearer and more obvious in terms of significantly slowing both the growth of the eye as well as then resulting in a lower glasses prescription," says lead study author Karla Zadnik, professor and dean of the College of Optometry at The Ohio State University.
The drugs’ safety was assessed in a sample of 573 participants aged three to 16. Both formulations were found to be safe and well tolerated, but a small number of participants experienced side effects such as sensitivity to light, allergic conjunctivitis, eye irritation, dilated pupils, and blurred vision.
The trial does have limitations, however. Participants who discontinued medication and switched to other treatments may have introduced potential bias. In addition, the representation of participants in the range of three to five years and 11 to 17 years of age was relatively lower.
Vyluma, the maker of the eye drops used in the trial, funded the study and was involved in the design and conduct of the trial, including the interpretation of the data.
- JAMA Ophthalmology. Efficacy and Safety of 0.01% and 0.02% Atropine for the Treatment of Pediatric Myopia Progression Over 3 Years.
- Ohio State University. Eye drops slow nearsightedness progression in kids, study finds.
- JAMA Ophthalmology. Increased Prevalence of Myopia in the United States Between 1971-1972 and 1999-2004.
- American Academy of Ophthalmology. Nearly 10 Million Adults Found to Be Severely Nearsighted in the United States.