Indiana University School of Optometry, Bloomington, IN, USA.
Toronto Eye Care, Toronto, ON, USA.
Ocul Surf. 2019 Apr;17(2):208-220. doi: 10.1016/j.jtos.2019.01.004. Epub 2019 Jan 14.
Vital dye staining has been used for over a century to assess the severity of ocular surface disease. However, despite common usage, a universally accepted "gold standard" grading scale does not exist for corneal and conjunctival staining, which can impact the ability to diagnose and monitor ocular surface conditions such as dry eye. The Food and Drug Administration (FDA) and other international regulatory agencies rely on ocular surface staining as a primary endpoint for new drug approvals, so that absence of a "gold standard" scale may affect approval of new drug treatments. To begin to address this problem, we review existing, published grading scales in an integrated fashion, highlighting their differences and similarities to emphasize common themes and the methods and elements that are important in creating a standardized scale. Our goal is to aid the field in moving towards an accepted standardized grading scale for ocular surface staining that can be applied in clinic and research settings for a variety of ocular conditions.
活染料染色已经使用了一个多世纪，用于评估眼表面疾病的严重程度。然而，尽管普遍使用，但角膜和结膜染色并没有一个被普遍接受的“金标准”分级标准，这可能会影响到干眼病等眼表面状况的诊断和监测能力。食品和药物管理局（FDA）和其他国际监管机构依赖眼表面染色作为新药批准的主要终点，因此缺乏“金标准”量表可能会影响新药治疗的批准。为了解决这个问题，我们以综合的方式回顾现有的已发表的分级标准，突出它们的差异和相似之处，以强调共同的主题以及在创建标准化量表时重要的方法和要素。我们的目标是帮助该领域朝着一种被接受的标准化眼表面染色分级标准迈进，该标准可以在各种眼疾的临床和研究环境中应用。
