Paper title: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:March 2020
Reference:Br J Ophthalmol.
Summary
The DIMS (Defocus Incorporated Multiple Segments) lens was developed by Hong Kong Polytechnic University with the aim of inhibiting myopia progression in children.
The lens design consists of a 9mm central zone to provide the distance refractive correction with a surrounding 33mm width annulus made of multiple defocus segments. Each of these segments has +3.50D power and are 1.03mm in diameter. The multiple myopic defocus images from the segments are presented alongside clear distance vision for the wearer.
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.
The authors found the children who wore the DIMS lenses had 52% less myopia progression and 62% slower axial length growth compared with those who wore the SV lenses.
The conclusion was that the induced simultaneous vision from the multiple segments was effective in slowing myopia progression.
临床相关性
The DIMS lenses provided a significant reduction of 52% slower refractive change and 62% slower axial length elongation over 2yrs compared to SV lenses
- The authors found this was a comparable efficacy to that of other current myopia management options, where Orthokeratology gave approx. 60%,1,2soft bifocal contact lenses approx. 50-60%1,3,4大约50％5
- Eyecare practitioners can use DIMS lenses as an effective spectacle lens option for managing myopia
Visually, the DIMS design provided equivalent vision for distance and near to the SV lenses
- 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
Older children seemed to benefit more than younger children from wearing DIMS lenses during the study
- Age was associated with a greater slowing effect for 10-13yr olds than for those aged 8-9yrs olds
- Most of the children who showed continuing progression despite wearing the treatment DIMS lenses were aged 8-9yrs
- 作者认为这可能是由于不同的retinal contours with age giving higher peripheral hyperopia, therefore minimising the myopic defocus treatment effect in younger children
- 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。
Limitations and future research
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
- The older children (10-13yr olds) experienced improved results from the myopic defocus compared to the younger children
- 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 al5examined their results from using prismatic bifocals for myopia control, they found a similar discrepancy and that a child’s age, initial myopic error and parents myopic status influenced the outcome
- 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
- However it is possible that if the lenses were examined, the segments could be visible
- 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
- Consequently, further research is required into the impact of DIMS on quality of vision.
This was the first phase of Lam et al’s study into the performance of the DIMS lenses
- At the time of it being published, the second phase had yet to be completed.
- The aim was to further examine the continued use of DIMS lenses for the children already wearing them, as well as assessing the impact of introducing the lenses to those who had used the SV lenses.
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。
Measurement procedure
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。
The change in axial length was the difference between the mean axial length data at baseline and the final values after 2 years.
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.
Generalised estimating equations were used to account for missing data from 23 of the participants who dropped out of the study after the baseline data had been collected. The information collected from all of the subjects was adjusted for influences from covariates such as gender, age, time spent on near work and parental myopia. It was found that their allocated group, time and age had an effect on the extent of the changes seen for myopia progression and axial length.
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.
- The DIMS lens was shown to give 62% slower axial length growth compared to wearing a single vision lens with a mean difference of 0.34 +/- 0.03mm
- All of the children wearing SV lenses showed axial length elongation after 2 years, whereas 14% of the DIMS wearing group exhibited no elongation.
Conclusions
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。
Children wearing the DIMS lenses had shown a significant reduction in the progression in their myopia progression as well as their axial length growth, suggesting that the induced myopic defocus from the lens segments during wear is responsible for the results.
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
Title: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 To
Aim:To determine if ‘Defocus Incorporated Multiple Segments’ (DIMS) spectacle lenses slow childhood myopia progression.
Methods:2年的双盲随机对照试验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％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％。
Conclusions: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Clare
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 is a contact lens optician based in Kent, England. She is currently completing her Advanced Diploma In Contact Lens Practice with Honours, which has ignited her interest and skills in understanding scientific research and finding its translations to clinical practice.
References
- Smith MJ, Walline JJ. Controlling myopia progression in children and adolescents.Adolesc. Health Med Ther2015; 6:133-40
- Cho P, Cheung S-W. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomised clinical trial.投资Ophthalmol Vis Sci2014; 55:7423-32
- Lam CSY, Tang WC, Tse DY-Y et al. Defocus incorporated soft contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren; a 2-year randomised clinical trial.Br J Ophthalmol2014; 98:40-5
- Chamberlain P, Back A, Lazon P, et al. 3 year effectiveness of a dual-focus 1 day soft contact lens for myopia control.Contact Lens and Anterior Eye2018; 41：S71-S72
- Cheng D，Woo GC，Drobe B等。双焦点和棱镜双焦点眼镜对儿童近视进展的影响：一项随机临床试验的三年结果。JAMA OPHTHALMOL2014; 132:258-64
- Jaskulski，M，Singh，NK，Bradley，A和Kollbaum，PS。新型多段眼镜镜的光学和成像特性旨在减慢近视进展。Ophthalmic Physiol Opt2020;40：549–556。
