Department of Ophthalmology, Zagreb University Hospital Center, Zagreb, Croatia.
Department of Ophthalmology, Zagreb University Hospital Center, Zagreb, Croatia; School of Medicine, University of Zagreb, Zagreb, Croatia.
Cont Lens Anterior Eye. 2023 Apr;46(2):101776. doi: 10.1016/j.clae.2022.101776. Epub 2022 Oct 28.
To determine the diagnostic accuracy of non-invasive tear film break-up time (NIBUT) measured by the handheld lipid layer examination instrument.
108 patients were enrolled in this cross-sectional study and divided into two groups: patients with dry eye (n = 57) categorized by the presence of dry eye symptoms obtained by Schein Questionnaire and minimally-one objective dry eye sign (tear film break-up time <10 s or corneal, conjunctival and lid margin fluorescein staining), and healthy subjects (n = 51).
Dry eye subjects had significantly shorter NIBUT than healthy subjects (6 s vs 20 s, p < 0.001). Logistic regression analysis showed that shorter NIBUT values were excellent indicators of dry eye disease (p < 0.001), with consistency and no significant difference between measurements, even after standardizing the results for age and sex. NIBUT cut-off point to distinguish dry eye from healthy subjects was 12 s (sensitivity 90.2 %, specificity 88.5 %, PPV 92.5 %, NPV 85.2 %, LR +7.82, LR- 0.11, DOR 70.92, DE 89.6 %). Good, but lower accuracy was observed at cut-off value of 10 s (sensitivity 87.8 %, specificity 88.5 %, PPV 92.3 %, NPV 82.1 %, LR+ 7.61, LR- 0.14, DOR 55.2, DE 88.1 %). The area under the ROC curve (AUC) of 0.944 classified NIBUT as a diagnostic test with very high accuracy.
This study showed a high diagnostic accuracy of NIBUT measured by the handheld lipid layer examination instrument. This simple, reliable, objective and available instrument might regularly take place in routine, standard dry eye diagnostic and can be used by almost every eye specialist.
评估手持脂质层检查仪测量的非侵入性泪膜破裂时间（NIBUT）的诊断准确性。
本横断面研究纳入 108 例患者，分为干眼组（n=57）和健康对照组（n=51）。干眼组根据 Schein 问卷获得的干眼症状和至少一项客观干眼体征（泪膜破裂时间<10 s 或角膜、结膜和睑缘荧光素染色）进行分类。
干眼组的 NIBUT 明显短于健康对照组（6 s 比 20 s，p<0.001）。Logistic 回归分析显示，较短的 NIBUT 值是干眼疾病的优秀指标（p<0.001），即使在标准化年龄和性别后，测量结果仍具有一致性且无显著差异。NIBUT 截断值为 12 s 时可区分干眼与健康受试者（敏感性 90.2%，特异性 88.5%，PPV 92.5%，NPV 85.2%，LR+7.82，LR-0.11，DOR 70.92，DE 89.6%）。截断值为 10 s 时观察到的准确性略低（敏感性 87.8%，特异性 88.5%，PPV 92.3%，NPV 82.1%，LR+7.61，LR-0.14，DOR 55.2，DE 88.1%）。ROC 曲线下面积（AUC）为 0.944，表明 NIBUT 作为诊断试验具有很高的准确性。
本研究表明，手持脂质层检查仪测量的 NIBUT 具有很高的诊断准确性。这种简单、可靠、客观且易于获得的仪器可能会在常规、标准的干眼诊断中定期使用，几乎可以由每一位眼科专家使用。
