Three year follow up clinical study results of the defocus incorporated multiple segments (DIMS) spectacle lens

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Research Abstract Summary

纸标题：Myopia control effect of defocus incorporated multiple segments (DIMS) spectacle lens in Chinese children: results of a 3-year follow-up study

作者：Carley Sy Lam（1，2），Wing Chun Tang（3），Paul H Lee（4），Han Yu Zhang（3），Hua Qi（5），Keigo Hasegawa（5），Chi Ho，Chi Ho（3，2））

  1. 香港理工大学验光学院近视研究中心，香港九龙
  2. 眼睛与视觉研究中心（CEVR），香港
  3. 香港理工大学验光学院近视研究中心，香港九龙
  4. School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong
  5. Technical Research and Development Department, Hoya Corporation Vision Care Section, Shinjuku-ku, Tokyo, Japan

日期：2021年3月

Reference:Br J Ophthalmol。2021;doi：10.1136/bjophthalmol-2020-317664[Link to open access paper]

概括

香港理工大学设计的散焦型多个片段（DIMS）奇观镜头是为了控制儿童的近视，并基于近视散焦和同时视觉的原理。1它是由中央光学区组成的双重焦点镜头（9mm）用于校正距离折射误差和一个环形多焦距，多个段为 +3.50d（每个片段1.03mm的直径）。这种设计强加了近视散焦，同时在所有观看距离都为佩戴者提供清晰的视野。

This study forms the second part of a two-part 3-year study involving DIMS, both conducted by Lam et al. Part 1 of the study was conducted over 2 years to find that the DIMS lens wear slowed childhood adjusted myopia progression significantly (52%) and axial elongation (62%) compared with single vision (SV) spectacles.2 Link to Myopia Profile review of the two year DIMS study results:散焦纳入多个片段（DIM）奇观镜头慢慢近视进展：一项为期2年的随机临床试验

在研究的第二部分中，已经参加了第1部分的孩子们要么继续戴昏暗，要么从控制单一视觉转变为昏暗。与年龄匹配的历史群体相比，两个群体的近视进展和轴向长度伸长率均具有统计学上的显着降低，这在统计学上彼此之间并没有不同。

临床相关性

对DIMS组的DIM和控制均表现出近视进展的统计学显着降低

  • In comparison to the historical control group, DIMS resulted in a -0.18D reduction in myopia progression, and 0.08mm reduction in axial elongation
  • 与历史对照组相比，对DIM的控制导致近视进展的-0.30d降低，轴向伸长率降低了0.12mm
  • In both groups, at least 80% of the group progressed by <0.50D and over 50% exhibited axial elongation <0.1mm
  • 因此，DIMS成功地减少了一群香港中国儿童的近视发展。

近视进展and axial elongation of the DIMS group in the third year were similar to those in the first and second year

  • 基于先前的研究，在治疗的第一年将期望获得最大的治疗效果。
  • Further research is required to investigate possible mechanisms for this outcome.

There were no statistically significant differences in myopia progression and axial elongation in the third year between the two groups (p>0.05).

  • 尽管差异在统计学上没有不同，但对DIMS组的控制的近视和轴向长度的减少较大，该组的比例较高。进行<0.50D。与DIMS组相反，对DIMS组的控制是他们使用DIMS镜片治疗的第一年。如前所述，先前的研究表明，在治疗的第一年中获得了最大的治疗效果。3
  • However, as the difference between the groups is not statistically significant, this indicates that DIMS remains effective in slowing myopia progression in older children.

局限性和未来研究

研究的许多方面是局限性的

  • 受试者不是随机的
  • 控制对DIMS组和历史组之间的SER的差异限制了两组的直接比较。
  • The subjects were Hong Kong Chinese children, and hence further research is required to investigate the treatment effect gained in different populations

This study did not examine the rebound effect of DIMS lenses. Further research is required to examine this, as well as determining the optimal age of treatment.

The research project was funded by HOYA, who have commercialised the DIMS lens as MiYOSMART. This acts as a potential conflict of interest and may increase bias.

Full story

Purpose

为了确定继续佩戴昏暗镜头的儿童的近视进展，或者在2年近视控制试验后从单一视力转变为昏暗镜头。

Study design

Text

测量程序

SER and axial length were measured at 6-month intervals. Spherical equivalent was measured by cycloplegic auto-refraction, and axial length with an IOL Master.

Outcomes

在DIM和对照组之间的第三年，近视进展和轴向伸长率没有统计学上的显着差异（p> 0.05）。如下表所示，较高的对照组对DIMS组的比例<0.50d，并且表现出<0.1mm的轴向伸长。

％进展<0.5D ％进展> 1d ％轴向伸长<0.1mm
DIMS 80 5 52
Control to DIMS 87 2 58

与SER和AL变化中的历史对照组相比

12 month changes in SER and AL in the historical group were -0.35±0.40D and 0.18±0.13mm respectively. The myopia progression in the DIMS group in the third year was significantly less than in the historical group (mean difference -0.18±0.42D). Axial elongation was also less than in the historical control group (mean difference 0.08±0.15mm).

Control to DIMS compared with historical control group in SER and AL changes

在年龄，性别或轴向长度方面，历史群体的基线数据与对DIMS组的控制之间没有显着差异，但是，球形等效差异显着差异。这是因为历史群体与DIMS组匹配时发生的。因此，进行了基线球形等效调整，这揭示了对DIMS组的控制的速度明显慢于历史对照组（Ser -0.30±0.42d的平均差异，轴向长度为0.12±0.16mm）。

结论

在整个研究的三年中，儿童的近视进展和轴向伸长速度减慢了昏暗的镜头镜头，提供了进一步的证据，表明DIMS镜片是一种有效的近视控制策略。在第三年的对照对DIMS组中观察到了这种近视控制效果，表明年龄较大的孩子仍然会产生治疗效果。需要进一步的研究以深入了解DIMS磨损和最佳治疗年龄。

Abstract

标题：Myopia control effect of defocus incorporated multiple segments (DIMS) spectacle lens in Chinese children: results of a 3-year follow-up study

作者：Carley Sy Lam，Wing Chun Tang，Paul H Lee，Han Yu Zhang，Hua Qi，Keigo Hasegawa，Chi Ho

目标：为了确定继续穿着散焦的儿童的近视进展，在进行了2年的近视控制试验之后，在1年的时间内从单一视觉（SV）切换到DIMS镜片。

Methods:128 children participated in this study. The children who had worn DIMS lenses continued to wear DIMS lenses (DIMS group), and children who had worn SV lenses switched to wear DIMS lenses (Control-to-DIMS group). Cycloplegic spherical equivalent refraction (SER) and axial length (AL) were measured at 6-month interval. Historical controls were age matched to the DIMS group at 24 months and used for comparing the third-year changes.

Results:Over 3 years, SER and AL changes in the DIMS group (n=65) were −0.52±0.69D and 0.31±0.26 mm; these changes were not statistically significant over time (repeated measures analysis of variance, p>0.05).

SER (−0.04±0. 38D) and AL (0.08±0.12 mm) changes in the Control-to-DIMS group (n=55) in the third year were less compared with the first (mean difference=0.45 ± 0.30D, 0.21±0.11 mm, p<0.001) and second (0.34±0.30D, 0.12±0.10 mm, p<0.001) years.

Changes in SER and AL in both groups over that period were significantly less than in the historical control group (DIMS vs historical control: mean difference=−0.18±0.42D, p=0.012; 0.08±0.15 mm, p=0.001; Control-to-DIMS versus historical control: adjusted mean differences=−0.30±0.42D, p<0.001; 0.12±0.16 mm, p<0.001).

结论：在过去两年中使用DIMS眼镜的儿童中的第三年，近视控制效果持续了下来，并且在从SV转换为DIMS镜片的孩子中也显示了。

[Link to open access paper]

ailsa_120x120

关于Ailsa

AILSA LANE是位于英格兰肯特的隐形眼镜眼镜师。她目前正在以荣誉完成她的高级隐形眼镜实践文凭，这引发了她在理解科学研究并找到其对临床实践的翻译方面的兴趣和技能。

Clare Maher_small

关于克莱尔

克莱尔·马赫（Clare Maher）是澳大利亚悉尼的临床验光师，也是第二年医生，对研究分析和科学写作有浓厚的兴趣。

参考

  1. Lam CS，Tang WC，Lee PH，Zhang HY，Qi H，谷川K，到Ch。散焦的近视控制效果纳入了中国儿童中的多个片段（DIM）奇观镜头：一项为期3年的随访研究结果。Br J Ophthalmol。2021[Link to open access article]
  2. Lam Csy，Tang WC，Tse Dy-Y等。Defocus融合了多个片段（DIM）奇观镜头慢慢近视进展：一项为期2年的随机临床试验。Br J Ophthalmol 2020; 104：363–8。[链接到近视资料评论][Link to open access article]
  3. Brennan，N等。“近视控制功效”。视网膜和眼睛研究的进展，2020年。[链接到近视资料评论][Link to open access article]
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