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). 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. 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. 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.

中文翻译：

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新型一次性感觉计 (KeraSenseⓇ) 可改善神经营养性角膜炎的诊断和治疗

与 Cochet-Bonnet (CB) 感觉计相比，验证新型、经济高效、一次性无菌设备（KeraSenseⓇ，Dompè farmaceutici SpA，意大利米兰）的使用、重复性和再现性。其次，寻找一种简单、安全、快速且低成本的测试来诊断神经营养性角膜炎（NK）。该研究纳入了 16 名 NK I 期患者、25 名糖尿病 (DM) 患者和 26 名健康受试者。通过 CB 和 KeraSenseⓇ 评估角膜敏感性 (CS)。对新型一次性感觉计的重复性、准确性和再现性进行了评估。通过ROC曲线分析计算NK诊断的特异性、敏感性和截止值。所有 NK 患者均显示 CS ≤ 40 mm，而健康患者均未显示 CS 值 < 50 mm。 CB 测量值与一次性使用感觉器的 CS 评估值之间存在显着一致性 (p < 0.001)。一次性使用感觉计的重复性评估显示不同测量值之间具有 100% 的一致性 (p < 0.001)。再现性评估显示不同操作员之间的一致性为 99.6% (p < 0.001)。一次性感觉计的 55 mm 值足以排除 NK 诊断，而所有 NK 患者的值均≤ 35 mm。角膜低下/麻醉被认为是 NK 的标志。使用新型一次性感觉计将改善 NK 的诊断，节省时间并保证患者的安全。糖尿病患者尽管角膜检查结果正常，但可能显示 CS 损伤，表明 NK 处于临床前阶段，需要密切随访。