Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.
Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.
Cont Lens Anterior Eye. 2021 Aug;44(4):101362. doi: 10.1016/j.clae.2020.08.006. Epub 2020 Sep 10.
To evaluate the comparability, discriminative ability, and optimal thresholds for non-invasive tear film breakup time measurements obtained from the Oculus Keratograph 5M and Medmont E300 in detecting other signs and symptoms of dry eye disease, as defined by the TFOS DEWS II diagnostic criteria.
One hundred and thirty-four participants (53 male, 81 female), with a mean ± SD age of 48 ± 20 years, were recruited into a prospective, investigator-masked, diagnostic accuracy study. Dry eye symptomology, tear film parameters (including non-invasive Keratograph and Medmont breakup time), and ocular surface staining were evaluated in a single clinical session.
Significant positive correlation was observed between the two automated instruments (p < 0.001), although non-invasive breakup time measurements obtained from the Medmont were significantly longer (p < 0.001), and demonstrated greater intra-subject and inter-subject variability (all p < 0.001). The areas under the ROC curves exceeded 0.65 for both instruments, and the discriminative abilities were comparable (p = 0.53). The Youden optimal diagnostic threshold for non-invasive tear film stability measurements obtained from the Keratograph was ≤8 seconds, and the optimal cut-off for breakup time measurements obtained from the Medmont was ≤14 seconds.
Despite significant positive correlation, breakup time measurements obtained from the Keratograph and Medmont were not directly interchangeable. Measurements from the Medmont were significantly longer and demonstrated greater intra-subject and inter-subject variability, although the two automated, non-invasive methods for assessing tear film stability exhibited comparable overall performance in diagnosing dry eye disease.
评估 Oculus Keratograph 5M 和 Medmont E300 非侵入性泪膜破裂时间测量值在检测干眼病其他体征和症状方面的可比性、区分能力和最佳阈值，这些体征和症状由 TFOS DEWS II 诊断标准定义。
134 名参与者（53 名男性，81 名女性），平均年龄±标准差为 48±20 岁，被纳入一项前瞻性、研究者盲法、诊断准确性研究。在单次临床就诊中评估干眼症状、泪膜参数（包括非侵入性角膜图和 Medmont 破裂时间）和眼表面染色。
两种自动化仪器之间观察到显著的正相关（p<0.001），尽管 Medmont 获得的非侵入性破裂时间测量值明显更长（p<0.001），且表现出更大的个体内和个体间变异性（均 p<0.001）。两种仪器的 ROC 曲线下面积均超过 0.65，且区分能力相当（p=0.53）。Keratograph 获得的非侵入性泪膜稳定性测量的 Youden 最佳诊断阈值为≤8 秒，Medmont 获得的破裂时间测量的最佳截断值为≤14 秒。
尽管存在显著的正相关，但 Keratograph 和 Medmont 获得的破裂时间测量值不能直接互换。Medmont 测量值明显更长，个体内和个体间变异性更大，尽管用于评估泪膜稳定性的两种自动化非侵入性方法在诊断干眼病方面表现出相当的总体性能。
