Efficacy of combined orthokeratology and 0.01% atropine solution for slowing axial elongation in children with myopia: a 2-year randomised trial

Nozomi Kinoshita,Toshikatsu Kaburaki,Machiko Shimmura-Tomita,Yasuhiro Konno,Naoki Hamada,Yoshinobu Kanda,Akihiro Kakehashi

doi:10.1038/s41598-020-69710-8

Abstract

Eighty Japanese children, aged 8–12 years, with a spherical equivalent refraction (SER) of − 1.00 to − 6.00 dioptres (D) were randomly allocated into two groups to receive either a combination of orthokeratology (OK) and 0.01% atropine solution (combination group) or monotherapy with OK (monotherapy group). Seventy-three subjects completed the 2-year study. Over the 2 years, axial length increased by 0.29 ± 0.20 mm (n = 38) and 0.40 ± 0.23 mm (n = 35) in the combination and monotherapy groups, respectively (P = 0.03). Interactions between combination treatment and age or SER did not reach significance level (age, P = 0.18; SER, P = 0.06). In the subgroup of subjects with an initial SER of − 1.00 to − 3.00 D, axial length increased by 0.30 ± 0.22 mm (n = 27) and 0.48 ± 0.22 mm (n = 23) in the combination and monotherapy groups, respectively (P = 0.005). In the − 3.01 to − 6.00 D subgroup, axial length increased by 0.27 ± 0.15 mm (n = 11) and 0.25 ± 0.17 mm (n = 12) in the combination and monotherapy groups, respectively (P = 0.74). The combination therapy may be effective for slowing axial elongation, especially in children with low initial myopia.

Highlights

The prevalence of myopia is increasing w orldwide[1,2,3] and younger generations are affected more than others[4,5,6]
No subjects in either group were re-prescribed the OK lenses because their uncorrected distant visual acuities did not change by more than 0.30 logarithm of the minimum angle of resolution (logMAR) unit due to progression of their myopia. This is the first prospective study to evaluate the efficacy of combined OK and 0.01% atropine therapy for slowing axial elongation in children with myopia over a 2-year period
As a primary endpoint of this study, axial elongation over a 2-year period was more significantly suppressed by combined OK and 0.01% atropine therapy than OK alone

Summary

Introduction

The prevalence of myopia is increasing w orldwide[1,2,3] and younger generations are affected more than others[4,5,6]. We conducted a prospective interventional, parallel-group randomised clinical trial of combination treatment with OK and 0.01% atropine ophthalmic solution to investigate their additive or synergistic effects for slowing axial elongation in children with myopia.

Results

Conclusion