Purpose

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.

Methods

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.

Results

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.

Conclusions

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.

中文翻译：

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评估两种自动无创泪膜稳定性测量技术的诊断能力

目的

根据 TFOS DEWS II 诊断标准的定义，评估从 Oculus Keratograph 5M 和 Medmont E300 获得的无创泪膜破裂时间测量值在检测干眼病的其他体征和症状方面的可比性、辨别能力和最佳阈值。

方法

134 名参与者（53 名男性，81 名女性），平均 ± SD 年龄为 48 ± 20 岁，被招募到一项前瞻性、研究人员掩蔽的诊断准确性研究中。干眼症状、泪膜参数（包括无创角膜曲率和 Medmont 破裂时间）和眼表染色在单个临床会议中进行评估。

结果

尽管从 Medmont 获得的非侵入性分手时间测量值显着更长（p < 0.001），并且表现出更大的受试者内和受试者间变异性（所有 p < 0.001)。两种仪器的 ROC 曲线下面积均超过 0.65，判别能力相当（p = 0.53）。从 Keratograph 获得的无创泪膜稳定性测量的 Youden 最佳诊断阈值为 ≤ 8 秒，从 Medmont 获得的破裂时间测量的最佳截止值为 ≤ 14 秒。

结论

尽管存在显着的正相关，但从 Keratograph 和 Medmont 获得的破裂时间测量值不能直接互换。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整体性能，但来自 Medmont 的测量时间明显更长，并且表现出更大的受试者内和受试者间变异性。