Purpose

Since tear film stability can be affected by fluorescein, the Dry Eye Workshop (DEWSII) recommended non-invasive measurement of tear breakup time (NIBUT). The aim of this study was to investigate the agreement and repeatability of four different instruments in the measurement of NIBUT.

Methods

72 participants (mean 24.2 ± 3.6 years) were recruited for this multi-centre, cross-sectional study. NIBUT was measured three times from one eye using each of the instruments in randomized order on two separate sessions during a day, separated by at least 2 h. NIBUT was performed at three sites (Switzerland, Germany and UK) using three subjective instruments, Tearscope Plus (Keeler, Windsor, UK) (TS), Polaris (bon Optic, Lübeck, Germany) (POL), EasyTear Viewplus (Easytear, Rovereto, Italy) (ET) and the objective Keratograph 5 M (Oculus Optikgeräte GmbH, Wetzlar, Germany) (KER). As the latter instrument only analyses for 24 s, all data was capped at this value.

Results

NIBUT measurements (average of both sessions) between the four instruments were not statistically significantly different: TS (median 10.4, range 2.0–24.0 s), POL (10.1, 1.0–24.0 s), ET (10.6, 1.0–24.0 s) and KER (11.1, 2.6–24.0 s) (p = 0.949). The objective KER measures were on average (1.2 s ± 9.6 s, 95 % confidence interval) greater than the subjective evaluations of NIBUT with the other instruments (mean difference 0.4 s ± 7.7 s, 95 % confidence interval), resulting in a higher limits of agreement. The slope was -0.08 to 0.11 indicating no bias in the difference between instruments with the magnitude of the NIBUT. Repeated measurements from the two sessions were not significantly different for TS (p = 0.584), POL (p = 0.549), ET (p = 0.701) or KER (p = 0.261).

Conclusions

The four instruments evaluated for their measurement of tear stability were reasonably repeatable and give similar average results.

中文翻译：

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四种不同设备的一致性和可重复性，用于测量非侵入性撕裂时间 (NIBUT)。

目的

由于泪膜稳定性会受到荧光素的影响，干眼研讨会 (DEWSII) 建议对泪液破裂时间 (NIBUT) 进行非侵入性测量。本研究的目的是调查四种不同仪器在 NIBUT 测量中的一致性和可重复性。

方法

这项多中心、横断面研究招募了 72 名参与者（平均 24.2 ± 3.6 岁）。NIBUT 在一天中的两个单独会话中使用每种仪器以随机顺序从一只眼睛测量 3 次，间隔至少 2 小时。NIBUT 是在三个地点（瑞士、德国和英国）使用三种主观仪器进行的，Tearscope Plus（Keeler，Windsor，UK）（TS），Polaris（bon Optic，Lübeck，德国）（POL），EasyTear Viewplus（Easytear，Rovereto） , 意大利) (ET) 和物镜 Keratograph 5 M (Oculus Optikgeräte GmbH, Wetzlar, Germany) (KER)。由于后一种仪器仅分析 24 秒，因此所有数据均以该值为上限。

结果

四种仪器之间的 NIBUT 测量值（两次会话的平均值）在统计上没有显着差异：TS（中值 10.4，范围 2.0-24.0 秒）、POL（10.1、1.0-24.0 秒）、ET（10.6、1.0-24.0 秒）和KER (11.1, 2.6–24.0 s) (p = 0.949)。客观 KER 测量值平均（1.2 秒 ± 9.6 秒，95 % 置信区间）大于 NIBUT 与其他仪器的主观评估（平均差异 0.4 秒 ± 7.7 秒，95 % 置信区间），导致更高的限制的协议。斜率是 -0.08 到 0.11，表明仪器与 NIBUT 大小的差异没有偏差。对于 TS (p = 0.584)、POL (p = 0.549)、ET (p = 0.701) 或 KER (p = 0.261)，两次会议的重复测量没有显着差异。

结论

为测量撕裂稳定性而评估的四种仪器具有合理的可重复性，并给出相似的平均结果。