TY - JOUR
T1 - A multicenter clinical trial of orthokeratology in school-aged children and adolescents in Japan
AU - Goto, Tomoko
AU - Shiraishi, Atsushi
AU - Ohashi, Yuichi
AU - Negishi, Kazuno
AU - Tsubota, Kazuo
AU - Nakamura, Yo
AU - Hieda, Osamu
AU - Sotozono, Chie
AU - Kinoshita, Shigeru
N1 - Funding Information:
The authors thank Xiaodong Zheng, MD, PhD (Ehime University School of Medicine) for his invaluable advice and assistance on this paper.
Publisher Copyright:
© 2021, Japanese Ophthalmological Society.
PY - 2021/9
Y1 - 2021/9
N2 - Purpose: This study investigated the safety and efficacy of orthokeratology in myopic children in Japan. Study design: Prospective clinical trial. Methods: This study enrolled myopic children aged 6–16 years 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 3 years. Slit-lamp findings, visual acuity, intraocular pressure, subjective refraction, corneal topography, corneal endothelial cell density, corneal thickness, and axial length were regularly assessed. Results: This study included 96 eyes of 48 patients (average age, 10.7 ± 2.08 years). 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 4 weeks and 0.02 ± 0.21 logMAR at 3 years (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 3 years (p = 0.9933, Dunnett’s test). The average axial length was 24.70 ± 0.78 mm at baseline, 24.77 ± 0.80 mm at 12 weeks, and 25.32 ± 0.85 mm at 36 months. 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. Conclusion: Orthokeratology lens (BREATH-O CORRECT R) use in children demonstrated good efficacy and safety during 3 years of follow-up.
AB - Purpose: This study investigated the safety and efficacy of orthokeratology in myopic children in Japan. Study design: Prospective clinical trial. Methods: This study enrolled myopic children aged 6–16 years 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 3 years. Slit-lamp findings, visual acuity, intraocular pressure, subjective refraction, corneal topography, corneal endothelial cell density, corneal thickness, and axial length were regularly assessed. Results: This study included 96 eyes of 48 patients (average age, 10.7 ± 2.08 years). 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 4 weeks and 0.02 ± 0.21 logMAR at 3 years (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 3 years (p = 0.9933, Dunnett’s test). The average axial length was 24.70 ± 0.78 mm at baseline, 24.77 ± 0.80 mm at 12 weeks, and 25.32 ± 0.85 mm at 36 months. 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. Conclusion: Orthokeratology lens (BREATH-O CORRECT R) use in children demonstrated good efficacy and safety during 3 years of follow-up.
KW - Axial length
KW - Minors
KW - Orthokeratology
KW - Safety
KW - School-aged children
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U2 - 10.1007/s10384-021-00842-8
DO - 10.1007/s10384-021-00842-8
M3 - Article
C2 - 34050849
AN - SCOPUS:85107366030
VL - 65
SP - 624
EP - 631
JO - Japanese Journal of Ophthalmology
JF - Japanese Journal of Ophthalmology
SN - 0021-5155
IS - 5
ER -