Japanese journal of ophthalmology · 2021
A multicenter clinical trial of orthokeratology in school-aged children and adolescents in Japan.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Goto Tomoko, Shiraishi Atsushi, Ohashi Yuichi, Negishi Kazuno, Tsubota Kazuo, Nakamura Yo, Hieda Osamu, Sotozono Chie, Kinoshita Shigeru
Аннотация
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.
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.