误导®1day

Type:Contact lens - daily disposable

Manufacturer:CooperVision

Material:o黑手党A 60%水凝胶

参数:Base Curve 8.7mm, Diameter 14.2mm. Power range:-0.25 d*至-6.00d以0.25步骤。仅球能力。(*随区域而变化)

设计:利用技术在MiSight ActivControl®®1天s a dual-focus concentric ring design with alternating vision correction zones and treatment zones with +2.00D of defocus.

产品信息

误导® 1 day was the首先要获得美国FDA批准的软镜,以减慢儿童近视的进展(请参阅FDA指示脚注)。Misight®1天具有广泛的中央视觉校正区和两个用于提供近视散焦的治疗区域,因此无论学生大小如何,都存在大约等效量的校正焦点和近视散焦。1

Myopia control mechanism

关于误导双重焦点设计的第一个出版物是Anstice和Phillips,2011年,他将同心治疗区描述为创造simultaneous myopic retinal defocusduring both distance and near viewing.1

世界领先的研究员厄尔·史密斯三世(Earl Smith III)和同事描述了动物模型中同时散焦理论的最新科学探索 -read a recent publication here.

近视控制功效

Two randomized controlled trials of two and three years' duration have shown efficacy in slowing axial and refractive myopia progression in children aged 8-12 years. One six-year study has indicated likely benefit in older children 11-15 years. See the scientific paper summaries below.

Prescribing information

误导指南suggests first trial lens power selection based on the spherical equivalent refraction at the contact lens plane, and only adding extra minus if it improves distance vision. FDA prescribing indications (US only) are noted below.

误解的三年临床试验表明,敏锐度结果平均为6/6或20/20,与单一视力隐形眼镜没有什么不同。2

同行审查了关于误解和安全性的科学

  1. Ruiz-Pomeda et al 2018. MiSight Assessment Study Spain (MASS). A 2-year randomized clinical trial.[link to open access paper]

    在单个西班牙一个站点中,近视为8-12岁的儿童-0.75至-4.00d和Astigmatism <-1.00d <-1.00d均以误解或单一视觉(SV)眼镜作为控制。两年后,平均近视进度为-0.45d vs -0.74d和0.28mm和0.28mm和0.44mm的误I和SV奇观组,约为40%的控制效应。

  2. Chamberlain等人,2019年。近视控制的3年随机临床试验[link to open access paper][link to Myopia Profile paper review]

    Children aged 8-12 years with myopia -0.75 to -4.00D and astigmatism <1.00D wore MiSight or a Proclear 1 day single vision contact lens, in a multisite study in four countries. After three years, average myopia progression was -0.51D vs -1.24D and 0.30mm vs 0.62mm in the MiSight and SV contact lens groups respectively, representing around a 50-60% control effect. Distance and near acuity was similar in MiSight and SV, being 6/6 (20/20) or better throughout the study.

  3. Chamberlain et al 2020. Myopia Progression in Children wearing Dual-Focus Contact Lenses: 6-Year Findings(链接到研究文摘)[link to Myopia Profile abstract review]

    Children aged 11-15 years who participated in the 3-Year MiSight study (above) either continued in MiSight or were switched from Proclear 1 day single vision contact lenses into MiSight. The new-to-MiSight group showed no significant difference in their myopia progression over the second three year period, compared to the children who had worn them for six years. This suggests a myopia controlling effect in older children fit with MiSight.

  4. Ruiz-Pomeda等人,2019年。受控的随机临床试验误评估研究西班牙(MASS)的双眼和适应性功能[link to open access paper][link to Myopia Profile paper review]

    Measures of distance and near phoria, accommodative convergence / accommodation (AC/A) ratio, stereopsis, accommodative amplitude or accommodative response (lead/lag) were undertaken in children wearing MiSight versus single vision spectacles. Both groups showed similar results at all visits - there was no significant impact of MiSight on binocular vision function.

  5. Chalmers等人2020年。在回顾性队列研究小儿软接触透镜磨损安全研究中的不利事件率:RECS研究。[link to open access paper][link to Myopia Profile paper review]

    Data from seven US eye care clinics was reviewed alongside that from randomized, controlled clinical trials (Ruiz-Pomeda et al 2018 and Chamberlain et al 2019 MiSight studies) for children aged 8-12 years at soft contact lens fitting. The rate of microbial keratitis was 7.4 per 10,000 years-of-wear and corneal inflammatory events 0.66% per year. This fills an important gap in understanding safety in young wearers, with rates no higher than that in adults wearing SCLs.

  6. 伍兹等人2021年。在6年内,每天佩戴一次性隐形眼镜的儿童眼健康。[link to open access paper]

    上面引用的Chamberlain等人2019年和2020年研究的参与者,他们误读了六年或三年的Proclear 1天,而三年的误解则显示出与镜头前的磨损相比没有显着的生物显微镜变化,也没有严重的不良磨损事件。

近视概况relevant blog posts

近视概况有关误解的临床案例研究188金宝搏体育app苹果下载

制造商资源

新闻发布on CooperVision and myopia

FDA Indications for use (US only): MiSight® 1 day (omafilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤0.75 diopters of astigmatism. The lens is to be discarded after each removal.

References

  1. Anstice NS,Jr。双焦点软接触透镜磨损对儿童轴向近视进展的影响。眼科。2011年6月; 118(6):1152-61。(关联)
  2. Chamberlain P, Peixoto-de-Matos SC, Logan NS, Ngo C, Jones D, Young G. A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control. Optom Vis Sci. 2019;96(8):556-67.(关联)
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