纸标题：Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial
作者：Carly Siu Yin Lam（1），Wing Chun Tang（1），Dennis Yan-Yin Tse（1），Roger Pak Kin Lee（1），Rachel Ka Man Chun（1），Keigo Hasegawa（2），Hua Qi（Hua Qi（2），Takashi Hatanaka（2），Chi Ho至（1）
- 近视研究中心，香港理工大学验光学院
- 日本东京霍亚公司
Date:2020年3月
Reference:Br J Ophthalmol.
Summary
香港理工大学开发了昏暗的（散焦掺入多个部分）镜头，目的是抑制儿童的近视进展。
镜头设计由9mm的中央区域组成，可提供距离折射的距离折磨，周围的33mm宽度环由多个散焦段制成。这些段中的每一个具有 +3.50D功率，直径为1.03mm。从各个细分市场出现了多个近视散焦图像，并与佩戴者的清晰距离视觉呈现。
This study aimed to establish the influence the lenses had on children’s ocular development by randomly allocating DIMS lenses and single vision (SV) lenses to Chinese children, before assessing their myopia progression and axial length growth after two years daily use.
作者发现，与戴上SV镜头的孩子相比，穿着DIMS镜头的孩子的肌瘤进展减少了52％，轴向长度慢了62％。
The conclusion was that the induced simultaneous vision from the multiple segments was effective in slowing myopia progression.
临床相关性
与SV镜头相比
- The authors found this was a comparable efficacy to that of other current myopia management options, where Orthokeratology gave approx. 60%,1,2软双焦点隐形眼镜。50-60％1,3,4大约50％5
- 眼护理从业者可以使用DIMS镜头作为管理近视的有效镜面镜头选项
从视觉上讲，昏暗的设计为距离和靠近SV镜头提供了等效的视野
- 几乎没有适应性问题，除了最初略有外围模糊外，磨损变得不那么明显
- This information can be discussed with children and parents when considering DIMS spectacles
在研究期间，年龄较大的孩子似乎比年幼的孩子从戴昏暗的镜头中受益更多
- Age was associated with a greater slowing effect for 10-13yr olds than for those aged 8-9yrs olds
- 尽管穿着昏暗的镜头，大多数表现出持续进展的孩子都是8-9岁
- 作者认为这可能是由于视网膜轮廓不同，年龄有更高的外周绩质，因此最小化幼儿的近视散焦治疗效果
- 知道这可以帮助从业者决定哪些孩子可能会从分配昏暗的镜头中受益最大。DIM可以为年龄较大的青少年和不愿意或适合隐形眼镜的年龄较大的青少年和成年人提供近视纠正和控制选择。
局限性和未来研究
该研究仅包括在-1.00 to -5.00d范围内患有近视的孩子
- There is therefore no data, at present, on the expected results for higher myopia correction
- Future studies extending this range could provide insights as to the slowing effect possible
- They could also reveal the ideal wear time (in years) to maximise the effect from the lens design and the point at which no extra benefit can be achieved
The children participating in the study were aged between 8 and 13yrs old
- 与年幼的孩子相比
- It is uncertain if the DIMS lenses could maintain efficacy with children over 13yrs
- 有13％的昏暗的孩子，其中大多数年轻（8-9岁），有13％
- When Cheng et al5检查了他们使用棱镜双焦点控制近视控制的结果，他们发现了类似的差异，并且孩子的年龄，最初的近视错误和父母的近视状况影响了结果
- 用昏暗的镜头，作者只发现孩子的年龄与表现结果有关
- Additional research into age-related changes of the peripheral refraction and peripheral retinal shape and the subsequent reception of myopic defocus within the eye could help confirm the ideal age range for using DIMS lenses
The authors conceded that as this study featured only Hong Kong Chinese children, the results cannot be assumed to be the same for children of other ethnicities
- Repeating the clinical trial in other countries would confirm the effectiveness of the DIMS lens where different patterns of myopia incidence and progression will exist
The trial was masked and randomised and therefore the children and their parents ideally would be unaware of having received the DIMS treatment lens or the SV lens
- 但是，如果检查了镜头，则可能会看到这些细分市场
- 尽管这不会影响客观测量的结果，但它确实表明某些参与者可能已经意识到他们已经收到了治疗方案，因此在试验结束之前被“揭露”
这项研究的结果不同于其他研究，重点是DIMS镜头设计。
- The authors concluded that the DIMS lens did not reduce BCVA. However, a recent optical analysis by Jaskulski et al reported that the optics of the DIMS lens reduces contrast at high spatial frequencies compared to a dual-focus contact lens.6
- 因此，需要进一步研究DIM对视力质量的影响。
This was the first phase of Lam et al’s study into the performance of the DIMS lenses
- 它出版的时候,第二个phae had yet to be completed.
- 目的是进一步研究已经佩戴它们的孩子的持续使用DIMS镜头，并评估将镜片引入使用SV镜头的人的影响。
This second phase of the study has since been studied and reviewed on Myopia Profile:Myopia control effect of defocus incorporated multiple segments (DIMS) spectacle lens in Chinese children: results of a 3-year follow-up study.
完整的故事
目的
这项研究的目的是探索散焦掺入多个段（DIM）设计镜头的程度，可以减慢中国儿童的近视进展和轴向长度的伸长。
Study design
Lam et al conducted a randomised, masked prospective study of 183 Hong Kong Chinese schoolchildren aged 8-13yrs old between August 2014 and July 2017. The children were randomly assigned either the DIMS lens giving myopic defocus induced by multiple plus-powered segments or a single vision (SV) lens.
纳入标准包括确保儿童的屈光误差在-1.00至-5.00D之间，小于散光的1.50d，并且没有进行过近视控制。
测量程序
The children’s refractive error and axial length were measured at baseline and afterwards at six-month intervals during the study. A masked investigator used cycloplegic examination and an open-field auto-refractor (Shin-Nippon NVision-K5001) to record the refractive error and axial length was measured using IOLMaster (Carl Zeiss). Other parameters such as distance and near acuity, near phoria and accommodation were also noted at each visit.
The children were randomly selected to receive either the DIMS treatment lens (93 children) or SV lenses (90 children) and were unaware of which lens they received. They were asked to wear the spectacles for full-time use, with the wearing times and comfort of using the lenses confirmed with follow-up phone calls and questionnaires.
计算近视进程的变化是基线时平均环读循环结果与2年后最终结果之间的差异。
轴向长度的变化是基线时的平均轴向长度数据与2年后的最终值之间的差异。
How effective the DIMS lens is in reducing myopia was calculated by dividing the differences in the myopia progression and axial length between the DIMS and SV groups and then multiplying by 100 to give a percentage efficacy.
结果
Out of the original 183 children, 160 completed the trial wearing either DIMS (79 children) or SV lenses (81 children).
The baseline mean myopia refraction was -2.93 +/- 1.04D for the DIMS group and -2.70 +/- 0.98D for the SV group. The mean baseline axial length was 24.85 +/- 1.59mm for the DIMS group and 24.72 +/- 1.30mm for the SV group.
Both groups wore the lenses for an average time of over 15hrs daily.
使用广义估计方程来说明23名参与者的数据丢失，他们在收集基线数据后退出研究。从所有受试者中收集的信息进行了调整，以应对从性别，年龄，近工作和父母近视上花费的时间，年龄，时间的影响。发现他们分配的群体，时间和年龄对近视进展和轴向长度的变化的程度产生了影响。
调整数据以允许这些协变量后，皮尔逊相关性分析发现，折射的变化与DIMS组的儿童年龄显着相关，在该组中，大孩子的进展变化略有变化。SV镜头组没有发现重大变化。
近视折射错误的变化
- 佩戴DIMS镜头的儿童发现的平均进展为-0.41 +/- 0.06D，而SV镜头组为-0.85D +/- 0.08D。
- 显示DIMS镜头可提供近视误差进展的52％，而平均差为-0.44 +/- 0.09d。
- 从SV组中，有7％的儿童在2年的研究中没有表现出近视进展，而21.5％的儿童穿着DIMS镜头也没有同时发展。
Changes in axial length
- The mean axial length growth for the DIMS wearers was 0.21 +/- 0.02mm. The SV lens wearers showed 0.55 +/- 0.02mm elongation in comparison.
- 与佩戴单一视力镜头相比，DIMS透镜的轴向长度速度慢62％，平均差为0.34 +/- 0.03mm
- 所有佩戴SV镜头的孩子都表现出2年后的轴向长度伸长率，而14％的DIM佩戴组则没有伸长。
结论
与单视镜相比，每天佩戴两年时，DIMS透镜设计可有效减慢近视折射和轴向长度伸长的进展。
戴着昏暗镜头的儿童显示出肌无力进展的进展以及轴向长度的生长显着降低，这表明磨损过程中镜头片段诱导的近视散焦是结果的。
Due to its non-invasive nature, DIMS lens provides an alternative for eye care practitioners to offer to children to manage myopia progression.
Further research could confirm the optimum age and refractive error range for the full benefit.
Abstract
标题：Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial
作者：Carly Siu Yin Lam，Wing Chun Tang，Dennis Yan-Yin Tse，Roger Pak Kin Lee，Rachel Ka Man Chun，Keigo Hasegawa，Hua Qi，Takashi Hatanaka，Chi Ho，Chi Ho
Aim:确定“散焦合并了多个片段”（DIMS）奇观镜头慢慢的儿童近视进展。
Methods:A 2-year double-masked randomised controlled trial was carried out in 183 Chinese children aged 8–13 years, with myopia between −1.00 and −5.00 D and astigmatism ≤1.50 D. Children were randomly assigned to wear DIMS (n=93) or single vision (SV) spectacle lenses (n=90). DIMS lens incorporated multiple segments with myopic defocus of +3.50 D. Refractive error (cycloplegic autorefraction) and axial length were measured at 6month intervals.
结果：160名儿童完成了这项研究，DIMS组n = 79，SV组n = 81。在DIMS组中，在2年内的平均近视进度为-0.41±0.06 d，SV组为-0.85±0.08 d。在DIM和SV组中，平均（SE）轴向伸长分别为0.21±0.02 mm和0.55±0.02 mm。与SV组中的儿童相比，DIMS组的儿童的近视速度慢了52％（平均差异-0.44±0.09 D，95％CI -0.73至-0.37，p <0.0001）。同样，DIMS组的儿童的轴向伸长率较小62％（平均差异为0.34±0.04 mm，95％CI 0.22至0.37，p <0.0001）。21.5％的穿着DIM镜头的儿童在2年内没有近视进展，但穿着SV镜头的孩子只有7.4％。
结论:Daily wear of the DIMS lens significantly retarded myopia progression and axial elongation in myopic children. Our results demonstrated simultaneous clear vision with constant myopic defocus can slow myopia progression.
关于克莱尔
Clare Maher is a clinical optometrist in Sydney, Australia, and a second year Doctor of Medicine student, with a keen interest in research analysis and scientific writing.
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。
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