Abstract
Endothelial cell density (ECD) is a crucial parameter for the release of corneal grafts
for transplantation. The Lions Eye Bank of Baden-Württemberg uses the “Rhine-Tec Endothelial
Analysis System” for ECD quantification, which is based on a fixed counting frame
method considering only a small sample of 15 to 40 endothelial cells. The measurement
result therefore depends on the frame placement and manual correction of the cells
counted within the frame. To increase the sample size and create higher objectivity,
we developed a new method based on “deep learning” that automatically detects all
visible endothelial cells in the image. This study aims to compare this new method
with the conventional Rhine-Tec system. 9375 archived phase-contrast microscopic images
of consecutive grafts from the Lions Eye Bank were evaluated with the deep learning
method and compared with the corresponding archived analyses of the Rhine-Tec system.
Means, Bland-Altman and correlation analyses were
compared. Comparable results were obtained for both methods. The mean difference between
the Rhine-Tec system and the deep learning method was only − 23 cells/mm2 (95% confidence interval − 29 to − 17). There was a statistically significant positive
correlation between the two methods, with a correlation coefficient of 0.748. What
was striking in the Bland-Altman analysis were clustered deviations in the cell density
range between 2000 and 2500 cells/mm2 – with higher values in the Rhine-Tec system. The comparable results for cell density
measurement values underline the validity of the deep learning-based method. The deviations
around the formal threshold for graft release of 2000 cells/mm2 are most likely explained by the higher objectivity of the deep learning method and
the fact that measurement frames and manual corrections were specifically selected
to reach the formal threshold of 2000 cells/mm2 when the full area endothelial
quality was good. This full area assessment of the graft endothelium cannot currently
be replaced by deep learning methods and remains the most important basis for graft
release for keratoplasty.
Keywords corneal transplantation - deep learning - corneal endothelium - corneal bank - fully
automated