Did you know there are eye drops out there that can slow the progression of nearsightedness in children? A handful of medications have been studied, but we will focus on the one most commonly used: atropine.
What is atropine?
Atropine is a drug that can be administered topically, or by injection into veins (IV) or muscles (IM). If you have had your eyes dilated during an eye exam, the doctor likely used a drop called tropicamide. Atropine is in the same family of drugs as tropicamide, but the effects are stronger. In the eye, atropine blocks iris sphincter muscle contraction (causing pupil dilation and subsequently light sensitivity) and paralyzes ciliary muscle accommodation (causing blurry near vision).
Atropine has been proposed as a way to slow myopia progression since the mid 19th century, but only with the randomized controlled clinical trials of recent decades has it gained traction. It is now considered one of the three main methods of slowing myopia progression in clinical practice (along with orthokeratology and soft, center-distance multifocal contact lenses).
How does it slow nearsightedness?
Myopia, or nearsightedness, increases as a result of an increase in the length of the eyeball (the axial length). The goal of myopia management is to slow this progression during the years of significant eye growth so that the ending level of myopia is lower than it otherwise would be without intervention. Normal eye growth in kids is about 0.1mm per year. Our aim with myopia management is to keep the growth rate close to that, and ideally keep axial length less than 26mm overall. In terms of a prescription (the refractive error), we are aiming to see less than -0.50 diopter increase in myopia per year. If we can lower the number of people who develop high myopia, we can reduce the risk of developing the ocular complications that come with it, like myopic macular degeneration, retinal detachments, and glaucoma.
Although the exact mechanism is unclear, atropine is believed to act on receptors in certain tissues of the eye (namely, the choroid, retina and/or the sclera), inhibiting thinning and stretching (1). Studies have demonstrated this effect with high and low doses of atropine (2, 3, 4).
What have the studies shown, in a nutshell?
Several studies have found atropine to be safe and effective in slowing the progression of myopia. We will summarize the main studies here.
The ATOM study found atropine 1% to reduce the refractive error progression by nearly 80%, with very little axial elongation seen (5,6). With this high concentration comes significant side effects of blurry near vision, pupil dilation, and light sensitivity. That can make this concentration impractical for school-aged children. Higher concentrations of atropine have also been found to have a larger “rebound” effect. That means that the higher the concentration, the more rapid the myopia progression once treatment is stopped.
It is worth noting that even at this high concentration of atropine, there was still progression of nearsightedness in the study subjects. So our goal with atropine therapy, as with all myopia management strategies, is not STOPPING myopia, but SLOWING its progression.
Further studies have looked at the efficacy of lower concentrations of atropine. The ATOM 2 study tested three concentrations of atropine (0.5%, 0.1% and 0.01%) and found all three to slow the progression of refractive error. Atropine 0.01% was found to be about as effective as the higher two concentrations, but with the least side effects. Atropine 0.01% showed a 59% slowing in refractive error, but the axial length change was significantly less impressive (7). This lack of correlation has raised some questions about the actual efficacy of atropine 0.01%.
The LAMP study tested atropine 0.05%, 0.025%, and 0.01%. All three were well-tolerated with minimal side effects. Atropine 0.05% was found to be superior to 0.025% and 0.01%, slowing 1-year progression by 0.54 D and axial elongation 0.21 mm (8). The same trend was seen at year two; the efficacy of atropine 0.05% was double that of atropine 0.01% (9)
For more details on the main studies summarized here, check out the Atropine for Myopia Management: The Studies post.
So what concentration of atropine is best for myopia management?
The jury is still out. Atropine 0.01% had been the prevailing practice, but recent studies indicate that 0.01% atropine is likely not a strong enough concentration to slow axial length elongation if used as the only form of myopia control. In 2023, the results of a randomized clinical trial of school-aged children in the US showed that atropine 0.01% did not slow myopia progression or axial elongation when compared to placebo (10). While 0.01% is still being used, we are seeing more frequent use of slightly higher concentrations (0.025% and 0.05%). The LAMP study found that 0.05% was the optimal concentration for slowing myopia progression (11). Ultimately, it is up to the optometrists and ophthalmologists to determine what is best on a case-by-case basis (considering the patient’s age, risk for progression, effectiveness of prior treatments, etc). I currently use 0.05% in most cases.
When should atropine therapy be started?
We want to consider the age of myopia onset and the rate of myopia progression in determining this. We know that, in general, fast progression occurs between the ages of 8 and 12, so having a myopia management strategy in effect during that time is ideal. Many practitioners will consider initiating treatment when a child is first diagnosed with myopia, especially if he/she is at high risk for progression. But future research may suggest that we treat even earlier than that, in the “pre-myopia” phase.
How long should atropine therapy last?
Treatment should continue until stabilization of myopia is achieved. The COMET study found that by age 15, 48% in the study had stable myopia, 77% by age 18 years, 90% by age 21 years, and 96% by age 24 years (12). Thus, the majority of practitioners are likely to treat until at least late adolescence. It is also important to slowly taper atropine over time in order to reduce the likelihood of rebound.
Can atropine be used with other myopia management methods?
Yes! Although we don’t know the exact way atropine slows myopia progression, it is believed that atropine does so via a different mechanism than orthokeratology and soft multifocal contact lenses do. Thus, using atropine in conjunction with other therapies could have an additive effect. Early studies comparing ortho-K alone vs ortho-K with atropine are showing promising results (13), and more studies are currently underway.
What are the side effects? Are there safety concerns here?
As mentioned earlier, the primary side effects of topical atropine are light sensitivity secondary to pupil dilation, blurred near vision, and local allergic response. These side effects were more profound with higher concentrations of atropine. The study subjects treated with lower concentrations of atropine had minimal to no side effects.
The more serious side effects of atropine like dry mouth, urinary retention, altered mental status, constipation, and increased heart rate are more associated with SYSTEMIC use as opposed to TOPICAL use. These side effects are extremely rare. A small amount of any eye drop can be absorbed into the bloodstream, especially in young children; however, the low doses we are using in myopia management are not of concern. To be ultra conservative, punctal occlusion* can be used to minimize the amount of systemic absorption.
The studies we have on atropine thus far have been short-term; there are no long-term studies on the safety and efficacy of atropine for myopia control (that I am aware of at this time).
Using atropine for myopia management is considered “off-label.” What does that mean?
“Off-label” means a drug or device that is FDA approved for a particular indication is being used for some other medical purpose. Off-label use of medication happens often in health care. For instance, a steroid eye drop may be indicated for the treatment of inflammation and pain after eye surgery, but can be useful and beneficial in controlling many other types of inflammation that are not associated with eye surgery.
Atropine use for the management of myopia is considered off-label. That just means that atropine 1% ophthalmic solution’s FDA-approved indication is for “cycloplegia, mydriasis, and penalization of the healthy eye in the treatment of amblyopia,” and not explicitly for myopia management. Using a drug off-label is legal, and the FDA leaves it up to practitioners to prescribe or administer drugs within a legitimate health care practitioner-patient relationship. It is ultimately at the prescriber’s discretion, and many studies have validated the decision to do so with regard to using atropine for myopia management.
My two cents
If a child is able to pursue orthokeratology or soft multifocal contact lenses as the primary method of myopia management, that is ideal. We need to correct a child’s blurry vision regardless, so those two options achieve that while also slowing myopia progression. If a child is not achieving adequate control with orthokeratology or soft multifocal contact lenses, low-dose atropine can be added. In general, I would use low-dose atropine as a primary method of myopia control if working with a child that is not able to or does not want to wear contact lenses.
| CLIFFSNOTES: Commercially-available, higher concentrations of atropine are effective in slowing the progression of myopia, but come with significant pupil dilation and focusing difficulty. Recent studies have found that specially-compounded, lower concentrations of atropine have similar results but reduced adverse effects, and are thus more clinically preferred. Low-dose atropine is one of the three main methods we use to slow the progression of myopia. It can be used on its own, or in conjunction with another method. |
*Punctal occlusion: Immediately after drop instillation, close your eyes and use your finger to apply pressure at the point where the lower eyelid and the nose meet. Do so for a couple of minutes to reduce drainage.
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