Robboy Marc W, Hilmantel Gene, Tarver Michelle E, Eydelman Malvina B
Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
Eye Contact Lens. 2018 Jul;44(4):212-219. doi: 10.1097/ICL.0000000000000476.
The increased prevalence of myopia in the United States and other regions of the world, and the sight-threatening problems associated with higher levels of myopia have led to great interest in research designed to reduce these rates. As most of the progression of myopia occurs in childhood, these investigations have been directed toward slowing the progression of myopia in children. Treatments described to potentially slow the progression of myopia have included pharmacological interventions, multifocal spectacles, and multifocal correction created by contact lenses. Although some contact lens clinical trials have demonstrated promising results in slowing the progression of myopia, many of these studies have significant limitations, including only short follow-up times, limited randomization, and incomplete masking. Such limitations have underscored the need to develop a more robust clinical study design, so that future studies can demonstrate whether contact lenses, as well as other medical devices, can be used in a safe and effective manner to control myopia progression. We review previous key studies and discuss study design and regulatory issues relevant to future clinical trials.
在美国和世界其他地区，近视患病率不断上升，以及与高度近视相关的视力威胁问题，引发了人们对旨在降低这些比率的研究的极大兴趣。由于大多数近视进展发生在儿童时期，这些研究一直致力于减缓儿童近视的进展。描述的可能减缓近视进展的治疗方法包括药物干预、多焦点眼镜以及隐形眼镜产生的多焦点矫正。尽管一些隐形眼镜临床试验在减缓近视进展方面显示出了有前景的结果，但其中许多研究存在重大局限性，包括随访时间短、随机化有限以及遮蔽不完整。这些局限性凸显了开发更稳健的临床研究设计的必要性，以便未来的研究能够证明隐形眼镜以及其他医疗器械是否可以安全有效地用于控制近视进展。我们回顾了以前的关键研究，并讨论了与未来临床试验相关的研究设计和监管问题。
