Chamberlain Paul, Peixoto-de-Matos Sofia C, Logan Nicola S, Ngo Cheryl, Jones Deborah, Young Graeme
Clinical and Experimental Optometry Research Lab, Centre of Physics, School of Sciences, University of Minho, Braga, Portugal.
Ophthalmic Research Group, School of Optometry, Aston University, Aston Triangle, Birmingham, United Kingdom.
Optom Vis Sci. 2019 Aug;96(8):556-567. doi: 10.1097/OPX.0000000000001410.
Results of this randomized, double-masked clinical trial demonstrate the effectiveness of the MiSight soft contact lens in slowing myopia progression over multiple years.
The purpose of this study was to quantify the effectiveness of MiSight daily disposable soft contact lens in slowing the progression of juvenile-onset myopia.
Myopic children (spherical equivalent refraction, -0.75 to -4.00 D; astigmatism, <1.00 D) aged 8 to 12 years with no prior contact lens experience were enrolled in a 3-year, double-masked, randomized clinical trial at four investigational sites in four countries. Subjects in each group were matched for age, sex, and ethnicity and were randomized to either a MiSight 1-day contact lens (test) or Proclear 1-day (control; omafilcon A) and worn on a daily disposable basis. Primary outcome measures were the change in cycloplegic spherical equivalent refraction and axial length.
Of the subjects enrolled, 75.5% (109/144) completed the clinical trial (53 test, 56 control). Unadjusted change in spherical equivalent refraction was -0.73 D (59%) less in the test group than in the control group (-0.51 ± 0.64 vs. -1.24 ± 0.61 D, P < .001). Mean change in axial length was 0.32 mm (52%) less in the test group than in the control group (0.30 ± 0.27 vs. 0.62 ± 0.30 mm, P < .001). Changes in spherical equivalent refraction and axial length were highly correlated (r = -0.90, P < .001). Over the course of the study, there were no cases of serious ocular adverse events reported. Four asymptomatic corneal infiltrative (one test, three control) events were observed at scheduled study visits.
Results of this clinical trial demonstrate the effectiveness of the MiSight daily disposable soft contact lens in slowing change in spherical equivalent refraction and axial length.
这项随机、双盲临床试验的结果证明了MiSight软性隐形眼镜在多年来减缓近视进展方面的有效性。
本研究的目的是量化MiSight日抛软性隐形眼镜在减缓青少年近视进展方面的有效性。
8至12岁、近视（等效球镜度为-0.75至-4.00 D；散光<1.00 D）且无佩戴隐形眼镜经验的儿童在四个国家的四个研究地点参加了一项为期3年的双盲随机临床试验。每组受试者在年龄、性别和种族方面进行匹配，并随机分为MiSight 1日抛隐形眼镜组（试验组）或博乐纯1日抛隐形眼镜组（对照组； omafilcon A），每日更换佩戴。主要观察指标为睫状肌麻痹等效球镜度和眼轴长度的变化。
入组受试者中，75.5%（109/144）完成了临床试验（试验组53例，对照组56例）。试验组等效球镜度的未调整变化比对照组少-0.73 D（59%）（-0.51±0.64 D对-1.24±0.61 D，P<.001）。试验组眼轴长度的平均变化比对照组少0.32 mm（52%）（0.30±0.27 mm对0.62±0.30 mm，P<.001）。等效球镜度和眼轴长度的变化高度相关（r=-0.90，P<.001）。在研究过程中，未报告严重眼部不良事件病例。在预定的研究访视中观察到4例无症状角膜浸润事件（试验组1例，对照组3例）。
这项临床试验的结果证明了MiSight日抛软性隐形眼镜在减缓等效球镜度和眼轴长度变化方面的有效性。
