McDonnell Peter J, Pflugfelder Stephen C, Stern Michael E, Hardten David R, Conway Taryn, Villanueva Linda, Hollander David A
Wilmer Eye Institute, Johns Hopkins University School of Medicine, 600 N. Wolfe St., Maumenee 727, Baltimore, MD, 21287-0005, USA.
Baylor Eye Physicians & Surgeons Houston, 6565 Fannin NC 205, Houston, TX, 77030, USA.
BMC Ophthalmol. 2017 Dec 28;17(1):265. doi: 10.1186/s12886-017-0646-5.
The aim of this research is to initiate a 5-year natural history study of dry eye disease (DED) using objectively assessed and patient-reported outcomes, to explore the hypothesis that DED is a progressive condition that has substantive and measurable impacts not only on the ocular surface, but on quality of life and visual functioning. Our objective for this report is to examine the baseline data.
A multicenter, prospective, controlled, observational study of Level 2 (mild-to-moderate) DED patients based on International Task Force Delphi Panel severity grading, and controls, documented baseline measures (including tear film biomarkers and quality of life). Tear cytokine concentrations were also measured in the tear film. Patients were using artificial tears as needed.
Two hundred seventeen DED patients and 67 gender- and age-matched controls were enrolled. A majority were females and Caucasian and groups did not differ significantly in terms of gender, race, or age. Differences between DED and matched controls, at baseline, included mean scores for Ocular Surface Disease Index (31.7 vs 4.1, P < 0.0001), Schirmer test (5.7 vs 15.3 mm, P < 0.0001), corneal staining (1.4 vs 0.2, P < 0.0001), conjunctival staining (1.4 vs 0.3, P < 0.0001), and tear break-up time (5.7 vs 8.5 s, P < 0.0001). Tear cytokines levels were determined and included interferon-γ, interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, tumor necrosis factor-α, epidermal growth factor, IL-13, IL-17, IL-1α, and inducible protein-10. The mean levels of IL-8 and IL-6 were slightly higher in the DED group at baseline. Blurred vision was reported as moderate/severe/very severe at baseline in 57.6% of DED patients vs.10.5% of normal controls (P < 0.0001). DED patients reported greater reductions in work and non-work productivity, as well as greater need for visits to ophthalmologists during the prior year.
In this report of the baseline findings of a 5-year natural history study of DED, a striking disease burden is observed with regard to blurred vision, productivity, and visits to eye care practitioners in mild to moderate DED patients compared to normal subjects of similar ages and genders.
ClinicalTrials.gov NCT00833235 on January 30, 2009.
本研究旨在开展一项为期5年的干眼症（DED）自然史研究，采用客观评估和患者报告的结果，以探讨DED是一种进行性疾病这一假说，该疾病不仅对眼表有实质性和可测量的影响，还对生活质量和视觉功能有影响。本报告的目的是检查基线数据。
一项基于国际任务组德尔菲专家组严重程度分级的多中心、前瞻性、对照、观察性研究，纳入2级（轻度至中度）DED患者及对照，记录基线指标（包括泪膜生物标志物和生活质量）。还测量了泪膜中的泪液细胞因子浓度。患者根据需要使用人工泪液。
共纳入217例DED患者和67例年龄及性别匹配的对照。大多数为女性和白种人，两组在性别、种族或年龄方面无显著差异。DED组与匹配对照组在基线时的差异包括眼表疾病指数平均得分（31.7对4.1，P<0.0001）、泪液分泌试验（5.7对15.3mm，P<0.0001）、角膜染色（1.4对0.2，P<0.0001）、结膜染色（1.4对0.3，P<0.0001）以及泪膜破裂时间（5.7对8.5秒，P<0.0001）。测定了泪液细胞因子水平，包括干扰素-γ、白细胞介素（IL）-1β、IL-2、IL-4、IL-6、IL-8、肿瘤坏死因子-α、表皮生长因子、IL-13、IL-17、IL-1α和诱导蛋白-10。DED组基线时IL-8和IL-6的平均水平略高。57.6%的DED患者在基线时报告视力模糊为中度/重度/极重度，而正常对照组为10.5%（P<0.0001）。DED患者报告在前一年工作和非工作生产力下降更多，以及看眼科医生的需求更大。
在本项关于DED为期5年自然史研究的基线结果报告中，与年龄和性别相似的正常受试者相比，轻度至中度DED患者在视力模糊、生产力和看眼科医生方面存在明显的疾病负担。
ClinicalTrials.gov NCT00833235，于2009年1月30日注册。
