1 Introduction
Myopia has emerged as a major and rapidly escalating public health concern in India, particularly among school‐aged children. Recent epidemiological evidence from North Indian school populations indicates a significant prevalence of myopia, especially in urban and academically competitive environments [
1]. This increasing burden is clinically important because early‐onset myopia is associated with faster progression and a higher lifetime risk of vision‐threatening complications, including retinal detachment, myopic maculopathy, glaucoma, and early cataract [
2,
3].
Environmental and behavioral factors play a crucial role in the development and progression of myopia. Increased near‐work activities, prolonged digital screen exposure, reduced outdoor time, and high educational demands have been consistently associated with accelerated myopia progression in children [
3,
4]. These risk factors are particularly relevant in the Indian context, where rapid urbanization and lifestyle changes have contributed to a rising burden of childhood myopia.
Pharmacological intervention with atropine has emerged as one of the most effective evidence‐based strategies for controlling myopia progression. Early landmark trials demonstrated that atropine significantly slows myopia progression in children, with a clear dose‐dependent treatment effect [
5]. However, higher concentrations (e.g., 1%) were associated with adverse effects such as photophobia and reduced accommodation, which led to increasing interest in lower concentrations with better tolerability [
6].
Subsequently, the Low‐Concentration Atropine for Myopia Progression (LAMP) study provided strong randomized clinical evidence demonstrating a dose–response relationship across 0.01%, 0.025%, and 0.05% atropine, establishing low‐dose regimens as effective and safer alternatives [
7–
9]. Further randomized clinical evidence also supports the efficacy of low‐dose atropine in reducing refractive progression and axial elongation in pediatric populations [
10].
Despite strong global evidence, the applicability of these findings to Indian children requires careful evaluation due to differences in genetic background, environmental exposures, educational intensity, and healthcare access [
11,
12]. In recent years, several Indian clinical and observational studies have evaluated low‐dose atropine therapy; however, these studies are heterogeneous in design, sample size, and outcome reporting [
11–
15].
Therefore, a structured synthesis of Indian evidence is essential to guide clinical decision‐making and develop context‐specific myopia control strategies. This review aims to critically evaluate and integrate evidence from randomized trials, prospective studies, retrospective analyses, and real‐world clinical data on low‐dose atropine use in Indian children, while contextualizing these findings within the broader global evidence base.
2 Methods
2.1 Study Design
This review followed a structured narrative review framework to synthesize available evidence on the use of low‐dose atropine for myopia control in Indian children. The approach was designed to ensure transparency in study identification, selection, and synthesis while accommodating the methodological heterogeneity of available studies. Because the review primarily aimed to summarize and interpret existing clinical evidence rather than perform a quantitative meta‐analysis, formal systematic review protocol registration was not undertaken. However, the review methodology was predefined and implemented using structured search and selection procedures to enhance reproducibility.
2.2 Literature Search Strategy
A comprehensive literature search was conducted in major biomedical databases including PubMed, Scopus, Web of Science, Google Scholar, and the online archive of the Indian Journal of Ophthalmology. The search covered publications from January 2005 to October 2025, corresponding to the period during which low‐dose atropine began to emerge as an evidence‐based therapy for myopia control.
Key search terms included: “myopia control,” “low‐dose atropine,” “0.01% atropine,” “0.05% atropine,” “pediatric myopia,” “axial length,” “India,” “Indian children,” “myopia progression,” “randomized controlled trial,” and “cohort study.” Boolean search combinations were used to optimize retrieval of relevant studies. A representative search strategy included: (myopia OR myopic progression) AND (atropine OR low‐dose atropine) AND (children OR pediatric) AND (India OR Indian).
Reference lists of included studies and relevant review articles were also manually screened to identify additional eligible publications.
2.3 Inclusion Criteria
Studies were included if they met the following criteria:
1. Conducted in India or included a clearly identifiable Indian cohort.
2. Evaluated low‐dose atropine (≤ 0.05%) for myopia control; studies using higher concentrations were considered only for historical or dose–response context and were not included in the low‐dose synthesis.
3. Included participants aged 5–18 years.
4. Reported outcomes related to refractive progression and/or axial length changes.
5. Used randomized controlled, prospective, retrospective, or interventional study designs.
6. Published in peer‐reviewed journals in English.
2.4 Exclusion Criteria
Studies were excluded if they:
1. Used atropine concentrations greater than 0.05%.
2. Included adult populations (> 18 years).
3. Did not report outcomes relevant to myopia control.
4. Were case reports, editorials, commentaries, or letters without original data.
5. Were duplicate publications or preprints lacking peer review.
2.5 Study Screening and Selection
The reviewer independently screened titles and abstracts of identified records, followed by full‐text evaluation of potentially eligible studies. Discrepancies between reviewers were resolved through discussion and consensus. Data from eligible studies were extracted into structured tables summarizing study design, sample size, participant age range, atropine concentration, follow‐up duration, refractive outcomes, axial‐length outcomes, and reported adverse effects.
Although intermediate concentrations such as 0.025% atropine have been evaluated in several international studies, including the LAMP, the present review focused primarily on 0.01% and 0.05% atropine. This decision was based on the fact that these two concentrations are the most commonly studied and reported in Indian clinical research and represent the doses most frequently used in routine clinical practice across India. In contrast, published Indian data evaluating 0.025% atropine remain limited, and therefore this concentration could not be meaningfully synthesized within the scope of the present review.
2.6 Quality Assessment
To strengthen methodological rigor, the quality of included studies was evaluated using the Joanna Briggs Institute critical appraisal tools appropriate to each study design. The appraisal assessed potential risk of bias related to participant selection, measurement reliability, follow‐up completeness, and confounding factors. Quality assessment findings were considered during interpretation of study outcomes and synthesis of evidence.
2.7 Data Synthesis
Given the heterogeneity in study design, follow‐up duration, and outcome measures, a quantitative meta‐analysis was not performed. Instead, a structured narrative synthesis was used to integrate findings across studies. Randomized controlled trials (RCTs) were prioritized when evaluating treatment efficacy, followed by prospective cohort studies and retrospective real‐world evidence. Particular emphasis was placed on patterns of refractive progression, axial length changes, dose–response relationships, and safety outcomes.
To contextualize Indian findings within the broader body of evidence, results from major international clinical trials including the Atropine for the Treatment of Myopia (ATOM) and LAMP were also considered during comparative interpretation.
3 Evidence From Indian Studies
Indian evidence evaluating low‐dose atropine for myopia control has expanded substantially over the past decade. Available studies include RCTs, prospective interventional studies, retrospective multicentric analyses, and investigations in specific high‐risk populations. A summary of the major Indian studies evaluating low‐dose atropine (0.01%–0.05%) for myopia control, including study design, treatment duration, refractive outcomes, axial length changes, and adverse effects, is presented in Table 1.
3.1 Randomized Controlled Trials
RCTs provide the most robust evidence on atropine efficacy in Indian children. A RCT comparing 0.01% and 0.05% atropine demonstrated a clear dose–response relationship, with greater reduction in refractive progression and axial elongation observed in the 0.05% group, although mild photophobia and near blur were more frequent compared with the 0.01% group [
6].
A multicentric RCT evaluating 0.01% atropine demonstrated significant reduction in axial elongation and refractive progression compared with control [
16].
These findings are consistent with results from major international trials such as ATOM and LAMP studies [
7–
10].
3.2 Prospective Controlled and Interventional Studies
Prospective studies further support the effectiveness of low‐dose atropine in routine clinical settings. Indian studies have demonstrated significant reductions in myopia progression and axial elongation compared with controls [
5,
16]. These findings suggest that low‐dose atropine is effective not only in controlled trial settings but also in real‐world clinical practice.
Additionally, Indian studies highlight those behavioral factors such as near‐work intensity, prolonged screen exposure, and reduced outdoor activity may influence treatment response and disease progression [
4,
15].
3.3 Retrospective Real‐World Evidence
Retrospective analyses provide important insights into large‐scale real‐world application across diverse clinical settings. A pan‐India multicentric retrospective study involving 732 children treated with 0.01% atropine demonstrated a substantial reduction in mean annual myopia progression from −0.75 D before treatment to approximately −0.27 D during the first year of therapy, with sustained benefits observed over follow‐up [
15].
3.4 Evidence in Special Populations
Evidence from specific subgroups further supports the applicability of low‐dose atropine across different age groups and disease severities. A study in children with high myopia demonstrated slower progression in those treated with low‐dose atropine compared with untreated controls [
4].
Additionally, studies in older children and adolescents suggest that low‐dose atropine remains effective beyond early childhood, although response may vary depending on baseline refractive error, age at initiation, and environmental exposure [
5].
The convergence of findings across randomized trials, prospective studies, retrospective analyses, and special‐population cohorts strongly supports low‐dose atropine as an effective, safe, and scalable intervention for myopia control in Indian children. The consistency of Indian evidence with global trials further strengthens its clinical applicability in routine pediatric ophthalmic practice.
4 Comparative Context: Global Evidence
A substantial body of international research supports the effectiveness of atropine in controlling childhood myopia progression. Early landmark trials, including ATOM study [
5] and its subsequent phase (ATOM2) [
6], demonstrated that atropine significantly reduces myopia progression in children and established a clear dose‐dependent treatment effect. Higher concentrations (e.g., 1%) showed greater efficacy but were associated with increased adverse effects, including photophobia and reduced accommodation, which limited their long‐term clinical acceptability.
LAMP study provided high‐quality randomized evidence demonstrating a dose–response relationship across concentrations of 0.05%, 0.025%, and 0.01%, with 0.05% showing the greatest reduction in refractive progression and axial elongation, and 0.01% offering a more favorable safety profile [
7–
9].
Further evidence from RCT has reinforced the effectiveness of low‐dose atropine in diverse populations. A RCT by Wei et al. demonstrated that treatment with 0.01% atropine significantly reduced myopia progression and axial elongation in children compared with placebo, supporting its long‐term efficacy and safety in real‐world clinical settings [
10].
Beyond randomized trials, observational and cohort studies from different Asian populations have consistently demonstrated similar benefits of low‐dose atropine therapy, supporting its generalizability across diverse ethnic and environmental contexts.
Several studies have also evaluated the safety profile of low‐dose atropine. Evidence indicates that 0.01% atropine does not produce clinically significant changes in intraocular pressure or major ocular physiological parameters, while only mild and transient side effects such as photophobia and near blur are typically observed [
11].
An important consideration in long‐term therapy is rebound progression following treatment cessation. Evidence from wash‐out phases of international studies suggests that abrupt discontinuation may lead to accelerated myopia progression, particularly in younger children. These findings highlight the importance of gradual tapering strategies and continued monitoring after treatment cessation [
12].
Overall, comparisons between international trials and Indian studies demonstrate strong consistency in treatment outcomes. Major global trials, including ATOM, ATOM2, and LAMP, show dose–response relationships similar to those observed in Indian studies, although regional differences in environmental exposure, lifestyle behavior, and healthcare access may influence treatment response. A comparison of treatment efficacy, axial‐length outcomes, and rebound effects reported in major international and Indian studies is summarized in Table 2.
5 Discussion
This review synthesizes evidence from RCTs, prospective studies, retrospective analyses, and special‐population cohorts to evaluate the efficacy and safety of low‐dose atropine for myopia control in Indian children. Overall, the findings are broadly consistent; however, the Indian literature demonstrates notable heterogeneity in study design, sample size, follow‐up duration, outcome measures, and population characteristics. These differences should be considered when interpreting national evidence and comparing it with international clinical trials.
5.1 Heterogeneity Across Indian Studies
Indian studies vary considerably in methodological design, including RCTs [
13,
16], prospective studies [
11,
13,
14], retrospective cohorts [
15], and special‐population analyses [
4,
5], as well as in sample composition and duration of follow‐up. Axial‐length outcomes were reported in some studies [
14,
15] but were not uniformly assessed across all cohorts. Additionally, younger age and higher baseline myopia—identified as predictors of faster progression in several Indian studies [
6,
7]—may partly account for variability in treatment response across populations.
Despite these differences, most studies consistently support 0.01% atropine as a first‐line therapy due to its favorable safety profile and meaningful reduction in myopia progression [
1–
6]. A simplified clinical pathway for initiating and monitoring therapy in Indian children is presented in Figure 1.
5.2 Comparison With International Evidence
The efficacy of 0.01% and 0.05% atropine observed in Indian children aligns closely with international evidence. The AIIMS Bibinagar RCT and the 24‐month Indian RCT [
6] demonstrate a clear dose‐dependent response consistent with findings from the LAMP trial [
7–
9]. This concordance strengthens the external validity of Indian data and supports generalizability of low‐dose atropine efficacy.
However, rebound progression following treatment discontinuation—well documented in international wash‐out studies [
6]—has not yet been systematically evaluated in Indian cohorts. This represents an important evidence gap and highlights the need for structured tapering strategies and post‐treatment monitoring.
The safety profile of low‐dose atropine reported across Indian studies is summarized in Table 3, demonstrating predominantly mild and self‐limiting ocular adverse effects with no reported treatment discontinuation.
5.3 Population‐Specific Factors in India
Several contextual factors may influence both baseline myopia progression and therapeutic response in Indian children. Urban studies consistently report earlier onset and faster progression of myopia, likely driven by intensive academic demands, prolonged near work, increased digital screen exposure, and reduced outdoor activity [
1,
3,
13].
Socioeconomic and geographic disparities further affect access to pediatric eye care, availability of compounded atropine formulations, and routine axial‐length monitoring, particularly outside tertiary centers. Additionally, younger age at initiation and higher baseline myopia—both common in Indian cohorts—are associated with relatively faster progression despite therapy [
16].
5.4 Sources of Variability in Treatment Response
Observed inconsistencies across studies may be attributed to several methodological and practical factors, including shorter follow‐up durations in some cohorts [
1–
3], small sample sizes in prospective studies [
3,
4], non‐uniform axial‐length monitoring [
6,
7], and variable treatment adherence, particularly among younger children.
Environmental and behavioral influences may further modify outcomes, with evidence suggesting that prolonged screen exposure and intensive near work may reduce the magnitude of treatment benefit [
5].
5.5 Implications of Study Design
Each study design contributes distinct insights. RCTs [
10,
16] provide the highest level of evidence and confirm a dose‐dependent therapeutic effect. Prospective studies [
11–
14] reflect real‐world clinical effectiveness and highlight behavioral modifiers of response. Retrospective multicentric studies [
15] demonstrate scalability and tolerability across diverse clinical settings in India. Special‐population studies [
4–
7] further support efficacy across varying age groups and severity profiles.
5.6 Limitations of the Evidence Base
Despite encouraging findings, several limitations must be acknowledged. Indian studies vary widely in sample size, methodological quality, and design. While randomized trials provide robust evidence, many studies are observational and therefore subject to selection bias, incomplete data capture, and inconsistent follow‐up.
Outcome heterogeneity is another key limitation. Although axial length is a critical structural endpoint, it was not uniformly measured across studies, and differences in instrumentation and reporting further limit comparability.
In addition, most studies have relatively short follow‐up periods (typically 1–2 years), limiting conclusions regarding long‐term efficacy, sustainability of treatment effect, rebound progression after cessation, and long‐term safety in Indian populations.
5.7 Overall Interpretation
Despite heterogeneity in study design, outcome measures, and population characteristics, the convergence of evidence from randomized trials [
10,
13,
16], prospective studies [
11–
14], retrospective analyses [
15], and special‐population cohorts [
4,
5] strongly supports low‐dose atropine as an effective, safe, and scalable intervention for myopia control in Indian children.
The strong concordance between Indian and international evidence [
5–
10] provides a robust scientific foundation for the development of standardized national guidelines for pediatric myopia management in India.
6 Conclusion
Low‐dose atropine, particularly 0.01%, is an effective and well‐tolerated therapy for myopia control in Indian children. These findings closely align with major global trials such as ATOM2 and LAMP. While 0.05% may provide slightly greater efficacy, its increased side‐effect profile warrants selective use. Given the rapid rise of childhood myopia in India, there is an urgent need for standardized treatment guidelines, long‐term monitoring protocols, and broader clinical adoption. Continued research, structured follow‐up frameworks, and strong policy support will be essential to maximize the public‐health impact of atropine therapy in India.
2026 The Author(s). Eye & ENT Research published by John Wiley & Sons Australia, Ltd on behalf of Higher Education Press.
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