Atropine in myopia – Does it reduce progression? Results of Phase 1 clinical trial in children attending a tertiary eye care center in South India

Abstract

Aim: The aim of this study was to analyze the effectiveness of low-dose atropine (0.01%) in reducing the progression of myopia in Indian children. Materials and Methods: This was a clinical trial of Indian children with axial myopia from January 2018 to May 2019, who were prescribed low-dose atropine (0.01%) to reduce progression. Parameters studied before and after starting low-dose atropine were as follows: visual acuity for distance and near, cycloplegic refraction, ocular alignment for distance and near, near point of accommodation (NPA), near point of convergence, axial length (AXL), pupil diameter (PDM), lens thickness (LT), anterior chamber depth (ACD), adverse reaction, compliance, and dropouts. Patients were evaluated at the initiation of treatment, at 1 month, and thereafter 6 monthly with a minimum follow-up of 6 months. Any increase in spherical equivalent (SE) of myopia was taken as progression and rapid progression of myopia was considered if there was a ≥0.5 DS increase in SE of myopia within 6 months. Results: Seventy-one eyes of 36 children who opted for low-dose atropine (18 males and 18 females) and 37 eyes of 19 age-matched children (10 females and 9 males) were included in the final study and control groups, respectively. The mean age was 8.31 years (standard deviation [SD] =1.191) in the cases compared to 9.68 years (SD = 3.606) in the controls. Progression of myopia was noted in 40 eyes (56.338%) in the study group as compared to 35 eyes (94.59%) in the control group (P = 0.00). Rapid progression was noted in 23 eyes (32.39%) in the study group as compared to 23 eyes (62.16%) in the control group (P = 0.003). The mean SE of myopia increased by 0.28 D (as compared to 0.63 D increase among the controls) (P = 0.01), and the mean AXL increased by 0.14 mm (as compared to 0.25 mm among the controls) in the study group at the end of 6 months (P = 0.01). There was also a statistically significant increase in mean PDM by 0.83 mm (P = 0.01) and receding of mean NPA by 1.14 cm in cases (P = 0.03). However, these changes were clinically insignificant. No significant changes were noted in ACD, LT, NPC, and ocular alignment. No adverse reactions were reported. Conclusion: Low-dose atropine (0.01%) therapy was able to reduce the progression of myopia in the study group as compared to the controls with a good tolerance and no change in the vision-related quality of life. Long-term follow-up is, however, needed for extrapolation into the general population.

Keywords

• children
• low-dose atropine
• myopia