Orthokeratology outperforms myopia control spectacles in slowing myopia progression: a prospective comparative study

To compare the effects of orthokeratology lenses and myopia control spectacles in slowing the progression of myopia in children. A total of 375 patients who underwent regular myopic examination at Nanjing Children’s Hospital from January 2023 to October 2023, were enrolled in this study. Patients were self-allocated into three groups: single vision spectacles group (SVS), orthokeratology lens group (Ortho-k), and myopia control spectacles group (Spectacle Lens with Highly Aspherical Lenslet Target, HALT), with 125 cases and 125 eyes in each group. All patients underwent spherical equivalent refraction (SER) and axial length (AL) measurements before wearing lenses and again one year afterward. Data from the right eye were included in the analysis. Changes in SER and AL after one year of lens wear were compared among the three groups. Additionally, Pearson linear correlation analysis was performed to assess the relationship between changes in AL and SER and baseline data in both the Ortho-k and HALT groups. After one year of lens wear, myopia progression in the SVS group was − 0.86 ± 0.42 D, in the Ortho-k group it was − 0.42 ± 0.52 D (p < 0.001 vs. SVS), and in the HALT group it was − 0.55 ± 0.36 D (p < 0.001 vs. SVS, p < 0.001 vs. Ortho-k). Axial elongation (AE) in the Ortho-k group was 0.18 ± 0.12 mm (p < 0.001 vs. SVS), in the HALT group it was 0.24 ± 0.14 mm (p < 0.001 vs. SVS, p < 0.001 vs. Ortho-k), and in the SVS group it was 0.36 ± 0.16 mm. The proportions of eyes showing SER regression after one year were 1.79% (2/112) in the SVS group, 29.63% (32/108) in the Ortho-k group, and 13.16% (15/114) in the HALT group (p < 0.001). Similarly, the proportions of eyes with AL regression were 0.00% (0/112) in the SVS group, 12.96% (14/108) in the Ortho-k group, and 6.14% (7/114) in the HALT group (p < 0.001). In this exploratory analysis, age was the only baseline factor showing a potential association with AE and SER progression (p < 0.05), showing a negative association with AE and a positive association with SER increase at baseline in both the Ortho-k and HALT groups. Adverse events were observed only in the Ortho-k group, with grade 1 corneal staining in 13.8% (15/108) and grade 2 staining in 3.8% (3/108) of patients. All corneal staining resolved without sequelae, and no severe adverse events occurred. Both Ortho-k lenses and HALT effectively and safely slow the progression of myopia and AE in children with myopia, with Ortho-k lenses showing statistically greater efficacy compared to HALT. The clinical significance of the minor absolute difference between these methods needs evaluation by larger randomized trials with longer follow-up.