1Department of Optometry, NIMS College of Allied Health Sciences, NIMS University, Jaipur, Rajasthan, India
2Department of Ophthalmology, National Institute of Medical Sciences and Research (NIMS), NIMS University, Jaipur, Rajasthan, India
*Corresponding Author: Labishetty Sai Charan, Research Scholar, Department of Optometry, NIMS College of Allied Health Sciences, NIMS University, Jaipur - 303121, Rajasthan, India. Email: charansai184@gmail.com; ORCID: 0000-0001-7983-7169
Background: Although 0.01% atropine is defined in children with myopia as the standard treatment, there is limited information in the literature on the functional tolerance of the drug in adolescents (12-18 years) with myopia. This paper fills in the research gap due to the importance of the evaluation of a 0.01% nightly atropine effect on pupillary response, visionary accommodation, and actual school adherence in a group of elderly children.
Novelty: This study is one of the limited randomized, placebo-controlled studies that are particularly focused on an adolescent group of subjects using standardized axial-length biometry as the primary structural correlate along with functional visual quality variables.
Methodology: A parallel-group, double-masked, randomized controlled trial randomized adolescents having progressive myopia to either nightly 0.01 percent atropine or placebo during 18 months. The functional safety was determined using photopic pupil diameter (swept-source optical biometry), Near point of Accommodation (NPA) and Intraocular Pressure (IOP). The standardization of assessments carried out in 500-lux photopic conditions was done to make measurements stable. The eye-level mixed-effects modeling was used to analyze longitudinal trajectories.
Results: Longitudinal retention was high with 182 out of the 200 eyes reaching the 18-month follow-up without any discontinuations that could have been attributed to any adverse events. Fulfillment effect was slight. The atropine group showed a mean pupil diameter change of +0.15 ± 0.20mm (p = 0.42) and a mean accommodative change of -0.20 ± 0.35D compared to placebo. Changes in intraocular pressure (IOP) were not statistically important between groups (p = 0.91). Minor, brief photophobia occurred in only 10% of participants, which has led to a high overall compliance rate of 94%.
Conclusion: Nightly 0.01-Atropine is at a successful safety-efficacy balance with a 47.5% axial elongation inhibition whilst not reducing the visual needs of an intensive academic setting. It is a sustainable first-line pharmacologic treatment of myopia in adolescents.
Future Directions: Future studies should focus on multi-centre studies in different populations and examine post-discontinuation "rebound effect" in specifically the adolescent cohorts to maximize long-term treatment stability.
Keywords: Myopia Control, Axial Length, Atropine 0.01%, Adolescent Vision, Randomized Controlled Trial.
How to cite this article: Charan LS, Mahaur V, Tripathi H. Functional Safety and Efficacy of 0.01% Atropine for Myopia Control in Adolescents: An 18-Month Double-Masked Randomized Controlled Trial. Int J Drug Deliv Technol. 2026;16(12s): 408-414. DOI: 10.25258/ijddt.16.12s.46
Source of support: Nil.
Conflict of interest: None