目的:为了验证使用,重复性,和一个新的再现性,成本效益高,一次性的,无菌装置(KeraSense®,DompèfarmaceuticiSpA,意大利米兰)与Cochet-Bonnet(CB)美度计相比。其次,为了识别一个简单的,安全,快速,和诊断神经营养性角膜炎(NK)的低成本测试。
方法:16例诊断为NK分期I的患者,25例糖尿病患者,26名健康受试者被纳入研究。角膜敏感性(CS)通过CB和KeraSense进行评估。重复性,准确度,并评估了新型一次性麻醉仪的可重复性。特异性,灵敏度,通过ROC曲线分析计算NK诊断的临界值。
结果:所有NK患者的CS≤40mm,而没有健康患者显示CS值<50mm。在CB测量值和CS的单次使用的美学计评价之间发现显著的一致性(p<0.001)。单次使用的美度计的重复性评估显示不同测量之间的100%一致性(p<0.001)。重复性评价显示不同操作者之间的一致性为99.6%(p<0.001)。一次使用的55毫米值的美度计足以排除NK诊断,而所有NK患者均显示值≤35mm。
结论:角膜麻醉不足被认为是NK的标志。使用新颖的一次性美感仪将有助于NK的诊断改进,节省时间,保证病人的安全。糖尿病患者尽管角膜检查结果正常,但可能显示CS受损,提示NK的临床前阶段,需要密切跟进。
OBJECTIVE: To validate the use, repeatability, and reproducibility of a new, cost-effective, disposable, sterile device (KeraSenseⓇ, Dompè farmaceutici SpA, Milan Italy) compared to Cochet-Bonnet (CB) esthesiometer. Secondly, to identify a simple, safe, rapid, and low-cost test to diagnose neurotrophic keratitis (NK).
METHODS: 16 patients with diagnosis of NK stage I, 25 patients with diabetes mellitus (DM), and 26 healthy subjects were included in the study. Corneal sensitivity (CS) was assessed by CB and KeraSenseⓇ. Repeatability, accuracy, and reproducibility of the novel disposable aesthesiometer were assessed. Specificity, sensitivity, and cut-off value for NK diagnosis were calculated by ROC curve analysis.
RESULTS: All NK patients showed a CS ≤ 40 mm, while none of the healthy patients showed a CS value < 50 mm. Significant agreement was found between CB measurements and the single use esthesiometer evaluations of CS (p < 0.001). Repeatability evaluations of the single use esthesiometer showed 100% agreement between different measurements (p < 0.001). Reproducibility evaluations showed 99.6% concordance between different operators (p < 0.001). A 55 mm value of the single use esthesiometer was adequate to exclude an NK diagnosis, while all NK patients showed a value ≤ 35 mm.
CONCLUSIONS: Corneal hypo/anaesthesia is considered the hallmark of NK. The use of the novel single-use esthesiometer will allow for a diagnostic improvement in NK, sparing time and guaranteeing patients\' safety. Diabetic patients despite normal corneal findings may show impairment of CS, suggesting a preclinical stage of NK, requiring a close follow-up.