Authors：Jeffrey Walline（1），Maria Walker（2），Donald Mutti（1），Lisa Jones-Jordan（1），Loraine Sinnott（1），Amber Gaume Giannoni（2），Katherine Bickle（1），Krystal Schulle（2），3），Alex Nixon（1,4），Gilbert Pierce（1），David Berntsen（2），用于眨眼研究小组
- The Ohio State University College of Optometry; Columbus
- 休斯顿大学验光学院；休斯敦，德克萨斯州
- 德克萨斯州休斯顿的私人执业
- Johnson＆Johnson Vision Care，Inc，佛罗里达州杰克逊维尔
Date:August 2020
参考：贾马。2020; 324：571-80
Summary
- +1.50D centre distance design did not significantly slow myopia progression or axial eye elongation relative to the single vision control
- 报道的43％的近视速度慢于43％， +2.50d中心距离多灶符合以下标准，即被认为具有临床意义：
- International Myopia Institute (>40% reduction)1
- Workshop organised by the US Food and Drug Administration (FDA, >30%)2
- 先前报道的3年误解研究报告了相对于单视力控制的近视少59％，轴向眼的生长降低了52％3
- 仅报告了35个不良反应，没有任何表示严重或导致CL磨损永久停用的反应
临床相关性
- 相对于单一视力CL，近视 +2.50D缓慢进展（43％）和轴向眼的生长（36％）的中心距离生物金属元素透镜具有 +2.50d的缓慢进展。
- 虽然报道的近视控制效应少于以前报道的Coopervision误导，但这项研究的结果表明+2.50中心距离生物金属多焦点透镜提供了有用的近视控制替代方案：
- for regions where MiSight is not available
- MiSight is available but off label prescribing is a consideration (MiSight is FDA approved for myopia control in the USA, the centre distance Biofinity is not FDA approved in the USA)
- 低水平的不良事件为每月软隐形眼镜作为儿童穿着的安全选择提供了证据
Limitations and future research
- Adjusted myopia progression of the SV (control) was slower than reported for other US based studies4-7
- 仅检查+1.50和 +2.50d添加 - 不回答是否添加功率是否高于+2.50
- The authors report that the control group in the MiSight study exhibited higher myopia progression (-1.24D) than the control group in the current centre distance multifocal study (-1.01D)
- however, the same 0.62mm change to axial length was reported for the control group in both studies, which suggests that valid comparisons between the two studies can be made
完整的故事
目的
本文仅涵盖了眨眼研究的目标，即比较晶状体类型之间近视进展的差异。将来的其他目的是在未来的论文中进行报道，是评估外周散焦对近视进展和眼睛形状变化的影响。
学习规划
3-year double masked study conducted across multiple sites in the USA. Children aged 7-11yrs with average refraction of -2.30D at baseline, were randomly assigned to wear CooperVision Biofinity soft contact lenses as either:
- 单一视觉（n：start = 98，end = 97）
- +1.50中心距离多灶（n：start = 98，end = 98）
- +2.50 centre distance multifocal (n: start=98, end=97)
Follow-up measurements were conducted annually, lenses were found to have been worn on average of 11.0±4.4 hours per day.
Measurement procedure
- Cycloplegic refraction (1 drop 0.5% proparacaine or tetracaine then 2 drops 1.0% tropicamide separated by 5 minutes)
- 自动磨蚀器（平均10次措施，大自WAM-5500）
- 轴向眼长（LENSTAR LS900，HAAG -Streit） - 在自动折射后立即采取
结果
折射change over 3 years
- SV: -1.01D (51% progressed >-1.00D)
- +1.50 MF：-0.85D（36.5％进展> -1.00d）
- +2.50 MF: -0.56D (16.8% progressed >-1.00D)
Axial length change over 3 years
- SV: 0.62mm (80.2% with eye growth >0.36mm)
- +1.50 MF: 0.55mm (61.5% with eye growth >0.36mm)
- +2.50 MF：0.39mm（47.4％的眼睛生长> 0.36mm）
Adverse events
35 moderate adverse events with no significant difference between groups (i.e. related to soft CL wear and not lens type) were reported as definitely or probably being related to lens wear: Giant papillary conjunctivitis (9); Infiltrative keratitis (8); Ocular allergy (7); Corneal epithelial defect/erosion (3); Contact lens associated red eye (2); Sterile corneal ulcer (2); Toxicity (2); Superior epithelial arcuate lesion (1); probable microbial keratitis (1). None of the events were reported as being serious or causing permanent discontinuation of CL wear.
Observations
The authors reported that the high add did not clinically alter ability for participants to see. However it's not stated in the methodology what contact lens power was prescribed to the children and if any adjustments from their spectacle best-vision sphere were required to maintain good acuity. The same Study Group published a paper in 2018 which indicated that their +2.50D Add wearing children needed an extra -0.50 to -0.75D of correction, compared to their spectacle best-vision sphere, to achieve good acuity in these lenses.8
Comparisons
要进行的最有用的比较是与误导研究进行的，该研究也经过了3年，并在下表中得到了强调。When assessing this table it is important to keep in mind that the authors reported slower progression in the single vision control for the current study (-1.01D) than reported for the MiSight study (-1.24D), though change to axial eye length at 0.62mm in the control group was the same across both studies.
Conclusions
- The high add +2.50 centre distance CooperVision Biofinity multifocal slowed myopia progression by 43% and axial eye elongation by 36% relative to the single vision control over three years
- A smaller, thoughnot statistically significant从 +1.50D添加的同一设计中发现了效果
- +2.50d添加了 +1.50D添加多灶的近视控制效应的近视控制效应有统计学上的显着差异。
抽象的
重要性减慢近视进展可能会降低视力威胁并发症的风险。
Objective来determine whether soft multifocal contact lenses slow myopia progression in children, and whether high add power (+2.50 D) slows myopia progression more than medium (+1.50 D) add power lenses.
Design, Setting, and Participants在位于俄亥俄州哥伦布市的2所验光学校和德克萨斯州休斯顿的两家验光学校进行了一项双掩盖随机临床试验。在2014年9月22日至2016年6月20日之间，招募了7至11岁的7至11岁的连续294名合格儿童，球形组成部分近视和少于1.00 d的Astigmatism招募了7至11岁的符合条件。24，2019。
Interventions随机分配参与者以佩戴高添加功率（n = 98），中等添加功率（n = 98）或单视（n = 98）隐形眼镜。
Main Outcomes and Measures主要结果是按平均值10个自动读物读数来衡量，环牙球形等效自动折射的3年变化。该研究有11个次要终点，其中4个进行了分析，其中包括3年的眼睛生长。
ResultsAmong 294 randomized participants, 292 (99%) were included in the analyses (mean SD age, 10.3 1.2 years; 177 60.2% were female; mean SD spherical equivalent refractive error, −2.39 1.00 D). Adjusted 3-year myopia progression was −0.60 D for high add power, −0.89 D for medium add power, and −1.05 D for single-vision contact lenses. The difference in progression was 0.46 D (95% CI, 0.29-0.63) for high add power vs single vision, 0.30 D (95% CI, 0.13-0.47) for high add vs medium add power, and 0.16 D (95% CI, −0.01 to 0.33) for medium add power vs single vision. Of the 4 secondary end points, there were no statistically significant differences between the groups for 3 of the end points. Adjusted mean eye growth was 0.42 mm for high add power, 0.58 mm for medium add power, and 0.66 mm for single vision. The difference in eye growth was −0.23 mm (95% CI, −0.30 to −0.17) for high add power vs single vision, −0.16 mm (95% CI, −0.23 to −0.09) for high add vs medium add power, and −0.07 mm (95% CI, −0.14 to −0.01) for medium add power vs single vision.
Conclusions and RelevanceAmong children with myopia, treatment with high add power multifocal contact lenses significantly reduced the rate of myopia progression over 3 years compared with medium add power multifocal and single-vision contact lenses. However, further research is needed to understand the clinical importance of the observed differences.
关于Paul
Dr Paul Giffordis a research scientist and industry innovator based in Brisbane, Australia, and co-founder of Myopia Profile.
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