International Consensus Paper on Low-concentration Atropine for Myopia Control

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Section 1. Mechanism of Action
Consensus Statement 1.1 Low-concentration atropine is a multilevel ocular growth modulator. Current evidence supporting actions across the retina-RPE–choroid–sclera axis, although the relative contribution of each tissue and pathway to the inhibition of axial elongation remains uncertain.
Consensus Statement 1.2 Choroidal thickening or preservation against choroidal thinning is a plausible intermediate response to atropine and may serve as a pharmacodynamic biomarker. However, choroidal thickness shows substantial variability, and its relationship with long-term axial-length control remains uncertain; the absence of measurable choroidal thickening does not exclude a treatment effect.
Consensus Statement 1.3 The precise mechanism of low-concentration atropine remains incompletely understood. It likely involves retinal growth-regulatory signaling and downstream effects on choroidal and scleral remodeling through multiple pathways, whose relative contributions remain uncertain.
Consensus Statement 1.4 The sclera is an important downstream effector tissue in atropine-mediated myopia control, but whether it is also a primary pharmacological site of action remains unresolved. Atropine may ultimately inhibit axial elongation by modifying scleral extracellular-matrix remodeling and biomechanical properties through signals originating in the retina and choroid.
Section 2. Initiation strategy, concentration selection, safety and tolerability
Consensus Statement 2.1 The choice of atropine concentration should take into account not only efficacy but also anticipated tolerability and potential impact on quality of life; low-concentration atropine is generally safe, with most adverse effects being mild but concentration-dependent.
Consensus Statement 2.2 Photophobia and blurred near vision are the most clinically relevant tolerability concerns and should be discussed routinely with children and caregivers before treatment initiation and during follow-up.
Consensus Statement 2.3 Low-dose atropine (0.01% to 0.05%) remains the preferred approach due to its balance of efficacy and reduced side effects.
Consensus Statement 2.4 Both myopia progression and response to atropine vary across ethnic groups. Therefore, individualized dosing strategies should take these factors into account, with atropine concentration titrated according to each patient’s response and tolerance.
Consensus Statement 2.5 Current evidence supports 0.05% atropine as the preferred first-line low-concentration option for East Asian children, with 0.025% as a reasonable intermediate alternative when tolerability is a concern.
Consensus Statement 2.6 Although 0.05% atropine also shows efficacy in White/European children, tolerability concerns may be greater and should be considered when selecting treatment concentration.
Consensus Statement 2.7 A concentration such as 0.01% may be considered for children with lower immediate progression risk, when tolerability is prioritized, or where access to standardized approved formulations makes this the most practical option, but close follow-up is required to determine whether escalation is needed.
Consensus Statement 2.8 Initiation of low-concentration atropine should be individualized rather than based on a single universal starting concentration for all children. High-risk groups should be started on a more efficacious concentration rather than the lowest available concentration.
Consensus Statement 2.9 Adherence and treatment burden should be assessed routinely in children receiving atropine, particularly when treatment response appears suboptimal, because inconsistent use may reduce effectiveness and lead to misclassification of apparent treatment failure as biological non-response.
Consensus Statement 2.10 Recommendations on concentration selection should account for formulation quality and regional evidence, because nominal atropine concentration alone may not fully predict clinical performance across different settings.
Section 3. Long-term efficacy and treatment duration
Consensus Statement 3.1 Low-concentration atropine can provide sustained myopia control during active treatment for at least 3 to 5 years.
Consensus Statement 3.2 Available long-term follow-up data are reassuring, with no observed atropine-related increase in major ocular complications; but regular reassessment is required during treatment.
Consensus Statement 3.3 Atropine treatment should generally continue through the active phase of myopia progression, with the need for ongoing therapy reassessed once myopia stabilizes during adolescence.
Consensus Statement 3.4 Treatment duration should be individualized based on age, recent refractive progression, axial elongation, and tolerability.
Section 4. Discontinuation and rebound after low-concentration atropine
Consensus Statement 4.1 Low-concentration atropine should not be routinely discontinued after a fixed treatment duration without considering the child’s age, recent refractive progression, and axial elongation, and residual risk of myopia progression.
Consensus Statement 4.2 Children should be monitored closely, particularly during the first 6–12 months after cessation, when post-treatment acceleration may be most pronounced.
Consensus Statement 4.3 If clinically significant myopia progression recurs after cessation, retreatment with atropine should be considered, guided by refractive and axial-length changes.
Consensus Statement 4.4 A tapering strategy may be considered when discontinuing 0.05% atropine, especially in younger or higher-risk children, but evidence is insufficient to define an optimal tapering regimen or to support routine tapering for all concentrations and treatment durations.
Section 5. Factors that influence treatment efficacy
Consensus Statement 5.1 The efficacy of low-concentration atropine is influenced by multiple interacting factors, including age, ethnicity, baseline myopic status, progression rate, family history, hyperopic reserve, and treatment duration.
Consensus Statement 5.2 Age is the most reproducible clinical modifier of atropine response; younger children generally show poorer control with lower concentrations and may require stronger treatment and closer monitoring.
Consensus Statement 5.3 Ethnic variation in treatment response should be interpreted as a modifier of expected efficacy rather than as a stand-alone prescribing rule, because apparent differences depend partly on baseline progression rates, concentration studied, and analytic method.
Consensus Statement 5.4 Genetic markers are not yet ready for atropine treatment selection, and no validated pharmacogenetic marker currently predicts the optimal concentration or likelihood of response.
Section 6. Combination Therapies
Consensus Statement 6.1 Combination therapy may provide additional treatment efficacy, but its efficacy is modality-specific and is not consistently superior to monotherapy across all treatment combinations.
Consensus Statement 6.2 Combination therapy is best considered for children with persistent progression despite good adherence to monotherapy, rather than as routine first-line treatment for all children.
Section 7. Low-concentration atropine for delaying myopia onset
Consensus Statement 7.1 Evidence for low-concentration atropine in premyopic children is limited and heterogeneous; in the LAMP2 trial, 0.05% atropine delayed myopia onset and reduced early axial elongation in selected high-risk children.
Consensus Statement 7.2 The preventive efficacy of 0.01% atropine remains uncertain, with inconsistent findings across studies and populations; evidence from progression-control trials should not be directly extrapolated to myopia prevention.
Consensus Statement 7.3 Delaying myopia onset has not yet been shown to permanently prevent myopia or reduce final adult refractive error, cumulative axial elongation, or myopia-related complications.
Consensus Statement 7.4 Atropine should not be routinely prescribed to all premyopic children; treatment decisions should be individualized according to age, refractive status, recent refractive change, axial elongation, parental myopia, environmental risk, anticipated benefit, treatment burden, adherence, adverse effects, and the feasibility of longitudinal monitoring.
Section 8. Formulations and Availability
Consensus Statement 8.1 Compounded low-dose atropine remains widely used, but substantial variability in labeling, concentration, storage instructions, pH, osmolarity, and beyond-use dating has been documented.
Consensus Statement 8.2 Commercially manufactured formulations may improve pharmaceutical standardization, stability, and comparability, although clinical evidence remains formulation-specific.
Consensus Statement 8.3 Approved low-concentration atropine products are available in some jurisdictions, but regulatory status, approved concentrations, indications, and access remain geographically variable.
Consensus Statement 8.4 Differences in formulation quality may contribute to heterogeneity in apparent treatment effect and should be considered when interpreting both clinical outcomes and published studies.
Section 9. Future Directions
Consensus Statement 9.1 Future atropine research should prioritize personalized treatment algorithms based on age, baseline progression, axial elongation, and population-specific response patterns.
Consensus Statement 9.2 The development of predictive biomarkers, including imaging and other biologically informed markers, is a major unmet need in atropine therapy.
Consensus Statement 9.3 Advanced drug-delivery systems such as sustained-release formulations and drug-eluting contact lenses are promising, but remain investigational and require rigorous safety and translational evaluation.
Consensus Statement 9.4 Long-term studies should focus on clinically meaningful endpoints, including cumulative axial elongation, retreatment needs, and eventual adult structural risk, rather than short-term refractive change alone.
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