Scientists from the University of Houston (UH) and The Ohio State University (OSU) are partnering on a first-of-its-kind clinical study to examine the potential for atropine eye drops to delay the onset of myopia among pediatric patients.
The collaboration is a result of the universities receiving two grants from the National Institutes of Health’s (NIH) National Eye Institute totaling a collective $25 million.
Let’s start with a look at atropine.
Atropine isn’t a new form of myopia management. In fact, the eye drop-formulated medication has been referred to as “the most effective” for consistently demonstrating its efficacy in slowing myopia.
To note: It has also been the subject of extensive research over the years for its myopic benefits, largely in low concentrations (0.01% – 0.05%) for slowing disease progression.
- See here for details on how it impacts the eye.
Has it received FDA approval?
While several formulations of atropine have (in the 1% concentration as atropine sulfate), these are largely for specific ophthalmic conditions, such as pupil dilation during eye exams, and treating:
- Amblyopia
- Mydriasis and cycloplegia
- Anterior uveitis
But it's important to note: There are currently no low-dose atropine products approved by the FDA for myopia control (although, just in the last few months, one company has made progress in advancing its new drug application for a low-dose atropine candidate to treat pediatric myopia).
Got it. Now to this new research.
UH and OSU scientists are co-leading a national study that will determine whether atropine eye drops can delay the onset of myopia in younger pediatric patients and also lessen disease progression over their lifetime.
- Specifically, they’re targeting patients aged 6 to 11, as myopia is known to begin between ages 8 and 13 (progressing up to around age 16)—and the eye grows the fastest right before the onset of myopia.
Supporting this target age group: Investigators referenced prior research that found pediatric patients whose hyperopia decreased to a specific measure by third grade were at the highest risk—with nearly 90% accuracy—for developing myopia just 5 years later.
And what do we know about the study so far?
- The name: Delaying the Onset of Nearsightedness Until Treatment (DONUT) (NCT06029530)
- The investigators: Co-principal investigators include two OSU professors and one UH professor of Optometry
- The design: Randomized, parallel-assignment, quadruple blind study
- The participants: 600+ pre-myopic patients (aged 6 to 11) with one eye meeting the following criteria (refractive error measured in spherical equivalent [SE]):
- Age 6: 0.50 to + 0.38
- Age 7: 0.50 to +0.25
- Age 8 to 11: 0.50 to plano
- See here for full inclusion criteria
- The setup: Patients will be randomized to one of three atropine concentrations—0.01%, 0.03%, or 0.05%—or a placebo, administered nightly
- The duration: 30 days
What’s being measured during this time period?
Investigators’ primary focus will be the timing of the onset of myopia in patients receiving atropine versus those who receive placebo drops.
A couple of notes on this:
- Participants in the placebo group who are diagnosed with myopia during the study will be crossed over to begin receiving atropine drops
- Regardless of their assigned group, any participant who develops myopia will also receive an annual voucher for corrective lenses, according to UH’s David Berntsen, a professor of Optometry and the study’s co-principal investigator
So, any predictions on the outcome?
Yes, actually … researchers hypothesize that atropine will reduce the number of pediatric patients who become myopic from 20% in the placebo group to 10% in the treatment (atropine) group.
Additionally, they predict that atropine will “slow pre-myopic eye growth by over 30%” over the study’s duration.
Interesting … last question: When can we expect data on this?
Excellent question. Unfortunately, the universities offered no specific timeline for patient enrollment or study initiation (and the trial’s Clinical Trials info appears outdated).
As always, stay tuned to learn more!