A recent study published in Acta Ophthalmologica, looked into the effects of 0.01% atropine eye drops as a tool to manage myopia progression, particularly among a predominately White, European population.
Give me some background first.
Findings from the Atropine Treatment Of Myopia (ATOM) 2 study posit that low-concentration atropine (0.01%) can aid in myopia management while avoiding the side effects of higher concentrations.
A number of reports from Asian countries showcase low-concentration atropine as a safe and effective pharmacological agent against the progression of myopia in children, though this has yet to be sufficiently tested among other regions such as Europe and North America.
Now talk about the study.
The Myopia Outcome Study of Atropine in Children (MOSAIC), based in Dublin, was a double-masked, randomized controlled trial (RCT) designed to test atropine for myopia control in a predominately White, European demographic.
This specific study looked at the initial 2-year results of what will eventually be a 3-year RCT.
Who are the participants?
A total of 250 myopic pediatric patients (ages 6-16) were recruited from July 2019 to September 2020. To note, these participants largely represented a predominantly White demographic of Ireland.
Tell me more.
Participants were randomly assigned to either receive 0.01% atropine or a placebo (2:1 ratio) to use every night in both eyes for 2 years.
What outcomes were being measured?
Cycloplegic autorefraction was conducted after instillation to primarily investigate cycloplegic spherical equivalent (SE) progression.
Additionally, axial length (AL) was measured with a low-coherence interferometry biometer.
Low-concentration atropine displayed “an excellent safety profile,” with the adverse effects between groups not producing a statistically significant difference.
Moreover, “myopia progression and axial eye growth in the MOSAIC cohort were reduced by 15.9% and 17.5%, respectively” in the initial 2 years.
What was the effect of ethnicity and eye color?
The 0.01% atropine eye drops exhibited statistically significant treatment effects for SE and AL that non-White participants did not observe.
Only a portion of the MOSAIC participants were non-White (n=43, 51% Asian), which resulted in an inconsistency when compared to the many Asian studies that observed atropine as highly effective among Asian children.
In terms of eye color, brown and green eyes observed much less significant treatment effects when compared to lighter eyes, specifically blue.
How did COVID-19 affect this study?
COVID resulted in the scrapping of the planned 6 month evaluations throughout the study and led to shortened 12 month evaluations for contact minimization.
Additionally, analysis of variance (ANOVA) was not conducted during the statistical analysis, as COVID caused measurements to be unequally spaced out.
Analysis was performed on participants who were affected in higher levels from COVID restrictions compared to participants who were recruited after the restrictions became more relaxed.
It was determined that participants least affected by COVID restrictions saw a larger treatment effect, with "40% less refractive progression and 32% less axial elongation in treated compared to untreated low COVID impact participants."
The authors of the study maintained that participant age might have an effect on this as well.
Ultimately, the study is in line with previous observations regarding the safety and efficacy of atropine as a method against myopia progression.
However, the authors concluded that these findings also display an efficacy disparity in regards to race, exhibiting an inconsistency with other studies.
This contributes to displaying a need for further study among various diverse populations.