One-year efficacy and tolerability of 0.05% atropine for myopia control in Estonia: a prospective cohort study

Abstract

Background Despite strong evidence from controlled trials, uncertainty remains about the real-world use of 0.05% atropine in patients with lighter irises due to tolerability concerns, and predictors of treatment response are poorly understood. Here, we evaluated the effectiveness, tolerability, and early biometric response to 0.05% atropine in clinical practice among patients with predominantly light irises.

Methods This prospective cohort study included 33 patients treated with 0.05% atropine (82% with light irises). Cycloplegic spherical equivalent refraction (SER) was measured at baseline and 3-month intervals. Axial length (AL), photopic pupil diameter, accommodation amplitude, and subjective side effects were monitored more frequently initially.

Results Median age at treatment initiation was 11.97 years, SER −5.38 D, and AL 25.42 mm. Over 12 months, SER changed by –0.078 ± 0.349 D (mean ± SD), and AL increased by 0.052 ± 0.115 mm. Eighty-eight percent of participants had a SER change of <0.5 D, and 91% had axial elongation of <0.2 mm, indicating clinically limited myopia progression. Photopic pupil diameter was larger, and accommodation amplitude was reduced throughout follow-up. Early in treatment, side effects, including photophobia and near-work difficulties, were common but minimally disruptive. Their incidence decreased rapidly and rarely required treatment modification. In exploratory analyses, early AL changes predicted 12-month AL outcomes, with associations detectable as early as 1 week and strengthening over time.

Conclusions 0.05% atropine was well tolerated and effective in this population with light irises. Early AL changes may predict 12-month treatment response. These findings support the implementation of 0.05% atropine in routine clinical practice in populations with light irises and highlight the potential for early AL monitoring to guide timely treatment adjustments.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study was funded by the European Union Horizon Europe research and innovation program under the Marie Sklodowska-Curie grant agreement No 101153901.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by the Tallinn Medical Research Ethics Committee.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present work are contained in the manuscript

List of abbreviationsALaxial lengthBCVAbest-corrected visual acuityDdioptreIQRinterquartile rangeQ1first quartileQ3third quartileSDstandard deviationSERspherical equivalent refraction

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