Hirabayashi Kyle J, Akpek Esen K, Ahmad Sumayya
New York Eye and Ear Infirmary of Mount Sinai, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Ocul Immunol Inflamm. 2022 Feb 17;30(2):282-289. doi: 10.1080/09273948.2022.2027461. Epub 2022 Feb 3.
Outcome measures used to assess efficacy of dry eye therapeutics have not been consistently applied in clinical settings, nor have they been shown to correlate with functional outcomes. We propose that corneal staining, a clinically meaningful dry eye parameter, should be used as a standard objective outcome measure across all clinical trials evaluating dry eye treatments. We justify this based on evidence regarding its relationship to vision and vision related quality-of-life. In addition, corneal staining has been shown to correlate with ocular surface inflammation, a well elucidated aspect of dry eye pathophysiology and an active area in therapeutics research. No one outcome measure explored herein correlates perfectly to this heterogenous disease. However, there is mounting evidence showing the correlation between corneal staining and functional visual indices. We hope that future clinical trials will standardize corneal staining as a measure to determine the efficacy of interventions and justify their clinical utility.
用于评估干眼症治疗效果的结局指标在临床环境中尚未得到一致应用，也未显示出与功能结局相关。我们建议，角膜染色作为一项具有临床意义的干眼症参数，应在所有评估干眼症治疗的临床试验中用作标准的客观结局指标。我们基于其与视力及视力相关生活质量的关系的证据来证明这一点。此外，角膜染色已显示与眼表炎症相关，眼表炎症是干眼症病理生理学中一个已充分阐明的方面，也是治疗研究的一个活跃领域。本文探讨的任何一项结局指标都与这种异质性疾病并非完全相关。然而，越来越多的证据表明角膜染色与功能性视觉指标之间存在相关性。我们希望未来的临床试验将角膜染色标准化，作为确定干预措施疗效并证明其临床效用的一项指标。
