Comparing automated and manual assessments of tear break-up time using different non-invasive devices and a fluorescein procedure

To evaluate the agreement and repeatability of an automated topography-based method for non-invasive break-up time (NIBUT) analyses in comparison with two other NIBUT procedures, the fluorescein procedure (fBUT), and with the manual assessment with the same device. In the first experiment, a semi-randomised crossover study was performed on forty-three participants (23.1 ± 2.1 years). NIBUT measurements were collected in a randomised order, in both eyes of participants with EasyTear View + (Easytear, Rovereto), Polaris, and Sirius + (CSO, Firenze). Then a fBUT was collected. The overall measurement procedure was repeated in a further session (retest) on the same day. In a second experiment, a retrospective randomised crossover study was performed on eighty-five NIBUT videos previously recorded by the Sirius+. Two observers assessed manually the videos and the NIBUTs were compared with the automatic ones. In the first experiment, ANOVA showed a significant difference between the four measures in both eyes (p < 0.001). Significant differences were found in the paired comparisons between each NIBUT procedure and fBUT (Wicoxon; p < 0.05). Sirius+ resulted in agreement only with Polaris in the left eye. Correlations between all NIBUT procedures resulted in statistical significance in both eyes. All procedures showed very good test-rest reliability. In the second experiment, a significant correlation between automated and manual NIBUT was found, but also a significant statistical difference between the two measurements, although clinically negligible (0.3 s). The investigated NIBUT devices perform differently from each other (and from fBUT), so they cannot be considered interchangeable. The automated measure of NIBUT with Sirius+ has a negligible clinical difference compared to manual assessment on the same device.