PDF(Pubmed)
Abstract：
OBJECTIVE: To assess the feasibility and the diagnostic accuracy of the new tool, DEvice© (AI, Rome, Italy), for screening patients with dry eye disease (DED).
METHODS: This study was performed at the University Magna Græcia of Catanzaro. Enrolled patients were classified as affected by DED (group 1) or not (group 2) using an already validated tool (Keratograph 5M, Oculus, Germany), evaluating the noninvasive keratograph breakup time (NIKBUT), tear meniscus height (TMH), meibomian gland loss (MGL), and bulbar redness. All the patients were then examined by means of DEvice©, which allowed the measurement of the relative humidity (RH) and temperature of the ocular surface. Symptoms were scored using the Ocular Surface Disease Index (OSDI) questionnaire.
RESULTS: Overall, 40 patients (17 males and 23 females, mean age 38.0 ± 17.1 years) were included: of these, 20 belonged to group 1 and the remaining 20 to group 2. Using Keratograph 5M, significant differences between groups 1 and 2 were detected for NIKBUT-first (respectively, 4.97 ± 1.85 vs. 13.95 ± 4.8 s; p < 0.0001) and for NIKBUT-average (10.55 ± 4.39 vs. 15.96 ± 4.08 s; p = 0.0003). No statistically significant changes were detected for TMH (p = 0.565), MGL (p = 0.051), and bulbar redness (p = 0.687). Using Device©, a statistically significant higher value of RH was found in group 1 compared to group 2 (respectively, 85.93 ± 10.63 vs. 73.05 ± 12.84%; p = 0.0049). A statistically significant correlation was found between RH and OSDI (r = 0.406; p = 0.009). The value RH showed a discriminating power to detect DED with an AUC = 0.782 (standard error 0.07264; 95% CI 0.6401-0.9249; p = 0.0022).
CONCLUSIONS: The DEvice© can effectively discriminate DED patients from healthy subjects. The parameter RH showed good sensitivity, making this tool ideal for a fast and noninvasive DED screening.
METHODS: This study was performed at the University Magna Græcia of Catanzaro. Enrolled patients were classified as affected by DED (group 1) or not (group 2) using an already validated tool (Keratograph 5M, Oculus, Germany), evaluating the noninvasive keratograph breakup time (NIKBUT), tear meniscus height (TMH), meibomian gland loss (MGL), and bulbar redness. All the patients were then examined by means of DEvice©, which allowed the measurement of the relative humidity (RH) and temperature of the ocular surface. Symptoms were scored using the Ocular Surface Disease Index (OSDI) questionnaire.
RESULTS: Overall, 40 patients (17 males and 23 females, mean age 38.0 ± 17.1 years) were included: of these, 20 belonged to group 1 and the remaining 20 to group 2. Using Keratograph 5M, significant differences between groups 1 and 2 were detected for NIKBUT-first (respectively, 4.97 ± 1.85 vs. 13.95 ± 4.8 s; p < 0.0001) and for NIKBUT-average (10.55 ± 4.39 vs. 15.96 ± 4.08 s; p = 0.0003). No statistically significant changes were detected for TMH (p = 0.565), MGL (p = 0.051), and bulbar redness (p = 0.687). Using Device©, a statistically significant higher value of RH was found in group 1 compared to group 2 (respectively, 85.93 ± 10.63 vs. 73.05 ± 12.84%; p = 0.0049). A statistically significant correlation was found between RH and OSDI (r = 0.406; p = 0.009). The value RH showed a discriminating power to detect DED with an AUC = 0.782 (standard error 0.07264; 95% CI 0.6401-0.9249; p = 0.0022).
CONCLUSIONS: The DEvice© can effectively discriminate DED patients from healthy subjects. The parameter RH showed good sensitivity, making this tool ideal for a fast and noninvasive DED screening.
摘要：
目的：为了评估新工具的可行性和诊断准确性，DEVIVE©(AI,罗马,意大利),用于筛选干眼症（DED）患者。
方法：本研究在卡坦扎罗的麦格纳格拉西亚大学进行。使用已经验证的工具（Keratograph5M，Oculus,德国),评估非侵入性角膜造影破裂时间（NIKBUT），撕裂弯月面高度（TMH），睑板腺丢失（MGL），和球根发红。然后通过DEVISK检查所有患者，允许测量相对湿度（RH）和眼表温度。使用眼表疾病指数(OSDI)问卷对症状进行评分。
结果：总体而言，40名患者（男性17名，女性23名，平均年龄38.0±17.1岁)包括：其中，20个属于第1组，其余20个属于第2组。使用角膜描记器5M，第1组和第2组之间的显著差异分别为NIKBUT-first(4.97±1.85vs.13.95±4.8s；p<0.0001）和NIKBUT平均值（10.55±4.39vs.15.96±4.08s；p=0.0003）。TMH没有检测到有统计学意义的变化（p=0.565），MGL（p=0.051），和球红（p=0.687）。使用设备©，与第2组相比，第1组的RH值具有统计学意义（分别为，85.93±10.63vs.73.05±12.84%；p=0.0049）。在RH和OSDI之间发现统计学上显著的相关性(r=0.406;p=0.009)。RH值显示出检测DED的辨别能力,AUC=0.782(标准误差0.07264;95%CI0.6401-0.9249;p=0.0022)。
结论：DEvice©可以有效区分DED患者和健康受试者。参数RH显示出良好的灵敏度，使这个工具理想的快速和无创DED筛查。
方法：本研究在卡坦扎罗的麦格纳格拉西亚大学进行。使用已经验证的工具（Keratograph5M，Oculus,德国),评估非侵入性角膜造影破裂时间（NIKBUT），撕裂弯月面高度（TMH），睑板腺丢失（MGL），和球根发红。然后通过DEVISK检查所有患者，允许测量相对湿度（RH）和眼表温度。使用眼表疾病指数(OSDI)问卷对症状进行评分。
结果：总体而言，40名患者（男性17名，女性23名，平均年龄38.0±17.1岁)包括：其中，20个属于第1组，其余20个属于第2组。使用角膜描记器5M，第1组和第2组之间的显著差异分别为NIKBUT-first(4.97±1.85vs.13.95±4.8s；p<0.0001）和NIKBUT平均值（10.55±4.39vs.15.96±4.08s；p=0.0003）。TMH没有检测到有统计学意义的变化（p=0.565），MGL（p=0.051），和球红（p=0.687）。使用设备©，与第2组相比，第1组的RH值具有统计学意义（分别为，85.93±10.63vs.73.05±12.84%；p=0.0049）。在RH和OSDI之间发现统计学上显著的相关性(r=0.406;p=0.009)。RH值显示出检测DED的辨别能力,AUC=0.782(标准误差0.07264;95%CI0.6401-0.9249;p=0.0022)。
结论：DEvice©可以有效区分DED患者和健康受试者。参数RH显示出良好的灵敏度，使这个工具理想的快速和无创DED筛查。
