在近视控制中有没有“金标准”的干预措施？

众所周知，近视是一个新起的公共卫生问题，特别是在东亚具有潜在而重大的经济和社会影响。

本次国际近视大会工作组由新加坡眼科研究所召集包括西太平洋卫生组织（WHO）及国际预防失明组织等近20个国际组织的代表参与，于2019年召开。

下文为本次国际近视大会发表的最新综诉，整理修订于2020年6月发表，希望此文能帮助感兴趣的家长更好的了解国际近视防控资讯。

Highlights from the 2019 International Myopia Summit on ‘controversies in myopia’

2019年国际近视大会聚焦“近视争议”

图丨英文原版综诉

ABSTRACT摘要

Myopia is an emerging public health issue with potentially signifificant economic and social impact, especially in East Asia. However, many uncertainties about myopiaand its clinical management remain. The International Myopia Summit workgroup was convened by the Singapore Eye Research Institute, the WHO Regional Offifice for the Western Pacifific and the International Agency for the Prevention of Blindness in 2019. The aim of this workgroup was to summarise available evidence, identify gapsor unmet needs and provide consensus on future directions for clinical research in myopia. In this review, among the many ‘controversies in myopia’ discussed, we highlight three main areas of consensus.

近视是一个新起的公共卫生问题，特别是在东亚具有潜在重大的经济和社会影响。然而，关于近视及其临床管理的许多不确定性一直存在。国际近视眼峰会于2019年召集新加坡眼科研究所、世卫组织和国际预防失明机构。峰会目的是总结现有证据，找出差距或不足，并就近视临床研究的未来方向达成共识。在这篇综述中，讨论了许多“近视眼的争议”，而强调了三个主要的共识领域。

CONTROVERSY 1争议 1

Should research in myopia treatments focus on preventing the dvelopment of Pathologic myopia rather than preventing of myopia progression ?

近视治疗的研究重点应该在如何预防病理性近视上而不是预防近视进展上？

There is increasing awareness that myopia is not just a refractive error that can be‘reversed’ by optical aids or refractive surgery. Myopia may progress to PM, a potentially blinding condition due to complications such as retinal detachment, myopic maculopathies and glaucoma. However, current clinical management of myopia is focused on its control, rather than interventions to prevent the development of PM and its complications. Given this context, two important aspects were highlighted and discussed.

人们越来越意识到，近视不仅仅是一种可以通过光学设备或屈光手术来“逆转”的屈光不正。近视是可能发展为PM（病理性近视）的，近视是一种潜在的致盲条件，因其并发症有视网膜脱离，近视黄斑病和青光眼。然而，目前对近视的临床管理侧重于控制，而不是采取干预措施来预防PM及其并发症的发生。在这方面，强调和讨论了两个重要方面。

Does controlling myopia in childhood prevent the development of pathologic myopia in adulthood?；A potential treatment target: is the sclera and choroid, or Bruch’s membrane a primary site of pathogenesis in pathologic myopia?

儿童期控制近视是否可以预防成年期病理性近视的发生? 潜在的治疗靶点:病理性近视的主要发病部位是巩膜、脉络膜或Bruch膜（编者注：位于眼底的组织结构名称）吗?

Conclusion 1结论 1

There is currently no definitive evidence to suggest that myopia control in childhood could prevent PM development later in life, and as such, long-term prospective studies are needed to answer this question. Research in myopia treatment would benefit from a shift in focus towards devising clinical therapies targeted at preventing AL elongation and resultant PM. However, there is currently insufficient evidence to support a primary site of pathology in PM. Thus, research into possible strategic targets for therapies may require focus on multiple sites, as current evidence suggest the possibility of BM, choroid and sclera playing a role in PM development.

目前还没有明确的证据表明在儿童时期控制近视可以预防PM（病理性近视）的发展。因此，需要进行长期的前瞻性研究来回答这个问题。研究近视治疗将受益重点转向针对防止眼轴延长和由此产生的PM。然而，目前还没有足够的证据支持PM的原发部位。因此，对可能的治疗策略目标需要集中在多个部位，目前的证据表明，基底膜、脉络膜和巩膜可能在PM的发生中起作用。

CONTROVERSY 2争议 2

There is currently no ‘gold standard’ intervention in the clinical management of myopia.

目前在近视的临床治疗中没有“金标准”的干预方式。

Atropine eye-drops, orthokeratology (Ortho-K), defocus multizone soft contact lens and defocus incorporated multiple segments (DIMS) spectacle lenses have been reported to be effective options for reducing myopia progression. Defocus multizone soft contact lenses and DIMS spectacles are recent innovations that have shown great promise for myopia control. A 3-year randomised clinical trial of MiSight dual-focus contact lens (CooperVision, Pleasanton, California, USA) (n=109) showed that myopia progression and axial elongation were 59% and 52% less in the MiSight arm than the single-vision contact lens arm. In the 2-year randomised clinical trial of DIMS spectacles (n=160), children on DIMS spectacles had significantly slower myopia progression and axial elongation (52% and 62%, respectively) over 2 years when compared with those wearing single -vision spectacle lenses. However, the effects of defocus multizone soft contact lenses on myopia progression are highly variable within individuals in the study as well as between studies, while the evidence for DIMS is limited to a single clinical trial. Thus, further studies are warranted for these novel interventions.

阿托品滴眼液、角膜塑形术、多弧离焦软接触镜片和多区正向光学离焦(DIMS)眼镜镜片，已被报道是减少近视进展的有效选择。多弧离焦软接触镜片和多点近视离焦镜片最近的创新，在近视控制方面显示出了巨大的前景。一项为期3年的MiSight(Cooper Vision，普莱森顿市，美国加利福尼亚州)，双焦隐形眼镜随机临床试验。结果显示，MiSight组的近视进展和轴增长分别比单焦组少59%和52%。

There is also growing interest in combining pharmaceutical and lens-based interventions. A recent study (n=60) evaluated the efficacy of atropine 0.01% eye-drops asan adjunctive treatment for children who have already been on Ortho-K treatment for a year. Axial elongation from only Ortho-K treatment in the first year (0.46±0.16 mm/year) decreased significantly with the addition of atropine in the second year (0.14±0.14 mm/year, p<0.001). The potential synergistic effects from combination therapy may be of benefit particularly for rapid myopia progressors.

同时，人们对于药物和镜片相结合的干预措施也越来越感兴趣。最近的一项研究(n=60)评估了0.01%阿托品滴眼液作为辅助治疗对已经接受了一年的OK镜治疗的儿童的疗效。随着阿托品的加入，第一年的轴增长显著降低(0.46±0.16 mm/年)(0.14±0.14 mm/年，p<0.001)。联合治疗的潜在协同效应可能对快速近视进展者尤其有益。

These treatment options are usually offered to patients based on the expertise of the eye care professional, influenced by a wide range of practice patterns around the world.However, the clinical management of myopia should ideally be evidence based,selected to provide the best risk-benefit profile for that individual. Recently, two interventions have emerged with the greatest potential for myopia control.

这些治疗方案通常是根据眼科专业人员的专业知识提供给患者的，受世界各地广泛实践模式的影响。然而在理想情况下，近视的临床治疗应以证据为基础，为患者提供最佳的风险和收益平衡。最近，出现了两种最有可能控制近视的干预措施。

Should orthokeratology be the treatment of choice for controlling myopia progression in children?；Should atropine eye-drops be used in children with low or no myopia to prevent myopia progression?

角膜塑形镜是控制儿童近视进展的首选治疗方法吗? 阿托品滴眼液是否适用于低近视或无近视的儿童，以防止近视进展?

Conclusion 2结论2

Overall, optimising the clinical management of myopia would benefit from an alignment of best practice patterns, with a tailored approach that can only be achieved with close collaboration among eye care practitioners. While current evidence suggests that low-dose atropine is a good option, potential side effects and the lack ofavailability in certain healthcare settings need to be considered. However, the use of atropine in children with low or no myopia requires further evidence from clinical trials prior to any recommendation. Ortho-K can be an effective option for myopia control but requires close clinical monitoring to avoid sight-threatening complications.

总的来说，优化近视的临床管理将受益于最佳实践的校准，而这种定制的方法只能通过眼科从业者之间的密切合作来实现。虽然目前的证据表明，低剂量阿托品是一个很好的选择，但需要考虑潜在的副作用和某些医疗机构缺乏可用性。然而，因为还没有得到进一步临床试验的证据，所以对于低度或无近视的儿童，建议持谨慎态度。角膜塑形镜是一种有效的近视控制方法，但是需要密切结合临床检测已避免视力损伤的并发症。

CONTROVERSY 3争议3

Current technology is inadequate for the diagnosis and monitoring of myopia-related complications.

目前的技术还不足以诊断和监测近视相关的并发症。

The burden of visual impairment arising from myopia comes primarily from PM and its complications such as MMD, which is now a leading cause of blindness in developed nations. Thus, the early detection and monitoring for myopia-related complications is important for timely intervention and prevention of visual impairment. The detection and evaluation of two major complications of PM, mCNV and myopia-associated optic neuropathy are discussed.

由近视引起的视力损害主要来自于PM(病理性近视）及其并发症，如MMD(变性性黄斑病变)，它现在是发达国家失明的主要原因。因此，早期发现和监测与近视相关的并发症对于及时干预和预防视力损害至关重要。本文讨论了PM、mCNV(新生血管性黄斑病变)和近视相关视神经病变两种主要并发症的检测和评估。

Is optical coherence tomographic angiography (OCTA) adequate for the evaluation of myopic choroidal neovascularisation? Can current diagnostics adequately diagnose an monitor glaucoma or myopia-associated optic neuropathy in high myopes?

光学相干断层血管造影术(OCTA)是否足以评估近视脉络膜新生血管? 是否能够充分诊断临床前期青光眼或近视相关视神经病变?

Conclusion 3结论3

The structure of the myopic eye adds complexity to the evaluation and early detection of sight-threatening complications, such as MMD and myopia-associated optic neuropathy, that cannot be bridged with current diagnostics. Collaboration between clinicians, researchers and industry is needed to optimise diagnosticand imaging technologies specifically for the myopic eye. Currently, OCTA imaging alone may be inadequate for evaluating mCNV, while the evaluation of myopia-associated optic neuropathy requires further research to accurately evaluate optic nerve damage in PM.Overall, there is an unmet need to explore and develop new imaging modalities for both structural and functional analyses and to establish normative databases for myopia in the long term.

近视眼的结构增加了评估和早期发现威胁视力的并发症的复杂性，如MMD(变性性黄斑病变)和近视相关视神经病变，这些都是目前的诊断无法弥补的。需要临床医生、专业人员和相关行业界之间的合作，以优化专门针对近视的诊断和成像技术。目前，单靠OCTA成像可能不足以评估mCNV，对近视相关视神经病变的评估需要进一步研究，以准确评估PM（病理性近视）中的视神经损伤。

总的来说，目前还没有满足探索和开发用于结构和功能分析的新的成像模式，以及建立长期近视的规范数据库的需求。

SUMMARY AND CONCLUSIONS总结与结论

The aim of this review is to highlight various aspects of clinical myopia discussedduring the IMS in 2019, including gaps in myopia research that require further study, consensus where evidence is not well established and a call to action for stakeholders to collaborate in the management of myopia.

本综述的目的是强调2019年IMS（国际近视大会）期间讨论的有关临床近视的各个方面，包括需要进一步研究的近视研究空白、证据尚不充分的共识以及呼吁利益攸关方在近视管理方面进行合作。

We acknowledge that the views presented are limited to that of the workgroup, which comprised an international panel from diverse backgrounds, all involved in myopia prevention or research. There are also potential biases arising from the representation of myopia experts mainly from Asia, but we have included a comprehensive review of the available published evidence to provide an objective summary in this article.

我们承认所提出的观点仅限于工作组的观点，工作组由来自不同背景的国际小组组成，均参与近视预防或研究。主要来自亚洲的近视专家代表也存在潜在的意见倾向，但我们在本文中对已发表的证据进行了全面的综述，以提供一个客观的总结。

Nonetheless, we have highlighted three key areas with regard to the clinical management of myopia, which may benefit from further research and development.

尽管如此，我们在近视的临床治疗中强调了三个关键领域，这些领域可能会从进一步的研究和发展中受益。

First, while controlling childhood myopia alone may reduce high myopia in adulthood, it maynot be enough to prevent the development of PM.There is an unmet need to search for potential treatment targets and to develop therapyinterventions that prevent progression to PM.

首先，虽然仅控制儿童期近视可以降低成年期高度近视，但这可能不足以预防PM（病理性近视）的发展。寻找潜在的治疗靶点和开发预防进展到PM（病理性近视）的治疗干预手段尚未出现。

Second, the clinical managementof myopia will benefit from comanagement from eye care professionals, such that the treatment plan may be tailored to patient needs while weighing the relative costs and benefits of each intervention.

其次，近视的临床管理将有利于眼科专业人员的管理。这样，在权衡每种干预措施的相对利弊的同时，治疗方案可以根据患者的需要量身定做。

Third, evaluation of myopia complications using current technologies present limitations that require collaboration between clinicians, researchers and industry partners to overcome in the long term. The workgroup advocated a paradigm shift in our approach to clinical management of myopia—one that necessitates co-ordinated action among the eye care community in our fight against the ‘myopia epidemic’.

第三，利用当前技术评估近视并发症存在一些局限性，需要临床医生、研究人员和行业合作伙伴长期合作才能克服。工作组主张我们对近视的临床管理方法进行一种规范化转变——在我们与“近视流行病”的斗争中，眼部保健社区必须采取协调行动。

注：此次中国大陆也有两位专家参加了本次国际近视大会，分别是上海市眼病防治中心、上海眼科医院的朱剑锋教授及温州医科大学眼视光医院的陈浩教授。非常感谢两位专家对中国近视防控事业的贡献！

作者：志汇眼科 张未

校审：于青