A multicenter clinical trial of orthokeratology in school-aged children and adolescents in Japan.

Abstract

This study investigated the safety and efficacy of orthokeratology in myopic children in Japan. Prospective clinical trial. This study enrolled myopic children aged 6-16years with a spherical equivalent of -1.00 D to -4.00 D and astigmatism of -1.5 D or lower, whose parents could manage contact lens use and could provide written informed consent. The children were treated with orthokeratology lenses (BREATH-O CORRECT R, Universal View Co., Ltd.) for 3years. Slit-lamp findings, visual acuity, intraocular pressure, subjective refraction, corneal topography, corneal endothelial cell density, corneal thickness, and axial length were regularly assessed. This study included 96 eyes of 48 patients (average age, 10.7 ± 2.08years). The average baseline spherical equivalent was -2.46 ± 0.97 D. The average baseline uncorrected visual acuity was 0.74 ± 0.32 logMAR, with significant improvement to -0.08 ± 0.18 logMAR at 4weeks and 0.02 ± 0.21 logMAR at 3years (both p < 0.001, Dunnett's test). The average baseline corneal endothelial cell density was 3053 ± 181 cells/mm2 and 3028 ± 213 cells/mm2 at postoperative 3years (p = 0.9933, Dunnett's test). The average axial length was 24.70 ± 0.78mm at baseline, 24.77 ± 0.80mm at 12weeks, and 25.32 ± 0.85mm at 36months. Although mild corneal epithelial disorders occurred in 18% of eyes, they were successfully treated with eye drops, enabling resumption of lens usage. No serious adverse events were observed. Orthokeratology lens (BREATH-O CORRECT R) use in children demonstrated good efficacy and safety during 3years of follow-up.