Toneasy Inc., Tokyo, Japan.
Department of Ophthalmology, School of Medicine, Keio University, Tokyo, Japan.
PLoS One. 2024 May 15;19(5):e0302568. doi: 10.1371/journal.pone.0302568. eCollection 2024.
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.
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.
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.
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.
Clinical trial registration number: jRCTs032220268.
我们研发了一种新型经眼睑眼压计,名为 TapEye 眼压计(TET),它基于对眼睑的触诊。我们的目标是评估一种通过眼睑提高眼压(IOP)测量准确性的方法。
参与者接受了技术员的标准化培训,并且必须能够使用 TET 进行研究纳入。然后,使用非接触眼压计和 Goldmann 压平眼压计(GAT)。所有参与者均被指示在基线(第 1 次就诊)和 1 个月(第 2 次就诊)时使用三种眼压计测量他们的 IOP。在第 2 次就诊时,使用第 1 次就诊时 TET 和 GAT 测量值之间的差值计算 TET 的校正 IOP 值(c-TET)。
在任何就诊时,TET 与 GAT 测量值之间均未发现显著相关性,但在第 2 次就诊时,c-TET 与 GAT 测量值之间的相关性具有统计学意义。右眼的 c-TET 与 GAT 测量值之间的平均差值为 0.4 ± 3.7 mmHg,左眼的平均差值为 0.5 ± 3.4 mmHg。
在根据初始就诊时 TET 和 GAT 测量值之间的差异校正 IOP 后,TET 的校正 IOP 值与第二次就诊时的 GAT 相关。TET 有潜力通过提供微创 IOP 测量工具来满足未满足的需求。
临床试验注册号:jRCTs032220268。