Fig 1.
CONSORT flowchart for the single-arm, open-label, clinical trial with the TapEye tonometer in normal and glaucoma subjects.
IOP = intraocular pressure; NCT = noncontact tonometer; GAT = Goldmann applanation tonometer; TET = TapEye tonometer.
Fig 2.
A, Overall appearance. B, The support plate is removed by sliding and repositioned onto the other eye. C, The height of the support plate can be adjusted to accommodate various face shapes.
Fig 3.
The appearance of the TapEye tonometer during the measurement.
A, Front view: tapping the button of the device with a finger. B, Lateral view. C, Magnified image of the tip and eyelid. The upper eyelid is naturally closed. The subject places the tonometer tip onto their eyelid, approximately 1 to 3 mm behind the lid margin of the upper eyelid; the tip position corresponds to the corneal center.
Fig 4.
Relationship of IOPs obtained from Tono-PenAVIA and TapEye tonometers using 3D-printed eyeball models with different CCTs.
The linear fit is plotted, and the correlation between the values is significant (Spearman r = 0.952, P<0.001). IOP = intraocular pressure; CCT = central corneal thickness.
Table 1.
Demographics of the participants.
Table 2.
Comparison of IOP obtained using the TapEye, noncontact, and Goldmann applanation tonometers.
Fig 5.
Scatterplots showing the association between the IOP measured by the TET (c-TET) and GAT.
A, TET and GAT measurements in the right eye at visit 1. The linear fit was not significant (r = -0.005, P = 0.964; Spearman correlation coefficient). B, TET and GAT measurements in the left eye at visit 1. The linear fit was not significant (r = 0.140, P = 0.157). C, TET and GAT measurements in the right eye at visit 2. The linear fit was not significant (r = -0.046, P = 0.647). D, TET and GAT measurements in the left eye at visit 2. The linear fit was not significant (r = 0.074, P = 0.460). E, c-TET and GAT measurements in the right eye at visit 2. The linear fit was significant (r = 0.408, P<0.001). F, c-TET and GAT measurements in the left eye at visit 2. The linear fit was significant (r = 0.414, P<0.001). TET = TapEye tonometer; GAT = Goldmann applanation tonometer.
Table 3.
Correlation of IOPs obtained from the noncontact tonometer and Goldmann applanation tonometer.
Fig 6.
Distribution of agreement between the c-TET and GAT measurements.
c-TET = corrected TapEye tonometer; GAT = Goldmann applanation tonometer.
Fig 7.
Bland‒Altman plot: A, Scatterplot showing the difference in IOP between corrected-TapEye tonometer (c-TET) and Goldmann applanation tonometer (GAT) measurements in the right eye.
The linear fit was significant (Spearman r = 0.530, P<0.001). B, Scatterplot showing the difference in the GAT and c-TET IOP measurements in the left eye. The linear fit was also significant (Spearman r = 0.451, P<0.01). Correlation plots: C, Scatterplot between the values of c-TET-GAT and GAT at visit 2 in the right eye (Spearman’s r = -0.135, P = 0.178). D, Scatterplot between the values of c-TET-GAT and GAT at visit 2 in the left eye (Spearman’s r = -0.192, P = 0.054).
Table 4.
Repeatability test for the intraocular pressure obtained with the TET at visit 2.