国际近视研究院《近视控制的行业指南和伦理考量》解读

Interpretation of IMI-Industry Guidelines and Ethical Considerations for Myopia Control Report

全球近视患病率不断攀升,近视程度不断加深,发生可致盲并发症的概率升高,近视已经成为全世界范围内视力受损以及盲的主要原因,近视防控也是全社会关注的重点领域。目前的防控方法包括户外活动、药物治疗及角膜塑形镜、周边离焦软性角膜接触镜、渐变焦和双焦眼镜配戴等,这些方法给参与治疗决策的研究人员和临床医生带来了许多伦理争议问题,比如在决策过程中需要考虑哪些潜在的利益冲突?对开处方的临床医生有什么监管上的考量?企业参与的近视控制研究涉及哪些伦理问题?学术组织应该如何适当传播近视控制研究的成果信息?开处方者的资质如何认证?近视防控医疗产品应该如何销售给开处方的医生以及患者?本文结合最新的临床研究和相关循证指南,对国际近视防控治疗的现状和相关问题及解决建议进行解读。

Along with the increasing global prevalence of myopia,severer myopia brings concerns about a higher risk of potentially blinding complications.Myopia is becoming one of the major causes of vision impairment and blindness in the world,and the myopia prevention and control has been a focus of the whole society.Management of myopia includes more outdoor activities,medications,orthokeratology,peripheral defocus soft contact lens,progressive addition lenses and bifocal lenses,etc.These methods have raised ethical disputes among regulatory bodies,manufacturers,academics and clinicians,who share an ethical responsibility to ensure that the products used for myopia control are safe and efficacious and that patients understand the benefits and potential risks of such products.The IMI-Industry Guidelines and Ethical Considerations for Myopia Control Report published in 2019 highlights the ethical challenges and provides stakeholders with recommendations and guidelines in decision-making,production development,spreading of research progress,prescribing,financial support and advertising of such treatments.Some common problems in combination with the latest clinical studies and relevant evidence-based guidelines were reviewed and reasonable solutions were recommended in this article.