Reporting checklist for randomised trial.

Purpose

We developed a novel transpalpebral self-tonometer called the TapEye tonometer (TET) based on palpation of the upper eyelid. Our goal was to evaluate a method for improving the accuracy of measuring intraocular pressure (IOP) through the eyelid.

Methods

Participants underwent standardized training by technicians and were required to be able to use the TET for study inclusion. Subsequently, a noncontact tonometer and Goldmann applanation tonometer (GAT) were used. All participants were instructed to measure their IOPs using the three tonometers at baseline (visit 1) and at 1 month (visit 2). At visit 2, the corrected IOP value measured by the TET (c-TET) was calculated using the difference between the TET and GAT measurements obtained at visit 1.

Results

No significant correlations were found between the TET and GAT measurements at any visit, but the correlation between the c-TET and GAT measurements at visit 2 was significant. The mean difference between the c-TET and GAT measurements was 0.4 ± 3.7 mmHg in the right eye and 0.5 ± 3.4 mmHg in the left eye.

Conclusions

After correcting the IOP based on the difference between the TET and GAT measurements at the initial visit, the corrected IOP value of the TET was correlated with that of the GAT at the second visit. The TET has the potential to address an unmet need by providing a tool for minimally invasive IOP measurements.

Trial registration

Clinical trial registration number:jRCTs032220268.