Clinical Assessment of Automated Non-Contact Tonometer: Interchangeability with Goldmann Applanation Tonometry and...

Background/Objectives: This study aimed to evaluate the clinical interchangeability of intraocular pressure (IOP) measurements between a non-contact tonometer (NCT), the TRK-3 OMNIA, and Goldmann applanation tonometry (GAT) and to assess the repeatability of TRK-3 measurements. Methods: This prospective, multicenter study included 120 subjects stratified into three IOP groups based on GAT measurements: low IOP (7-16 mmHg), intermediate IOP (>16 to <23 mmHg), and high IOP (≥23 mmHg). The study eye was randomly selected from each subject. IOP was measured using both TRK-3 OMNIA and GAT following a standardized protocol. Agreement between the two methods was evaluated using Bland-Altman analysis, 95% limits of agreement (LoA), and equivalence testing via the two one-sided test (TOST) approach with a predefined ±5 mmHg margin. Linear regression analysis was performed to characterize the relationship between TRK-3 and GAT measurements. The repeatability of TRK-3 measurements was assessed using the intraclass correlation coefficient (ICC), repeatability limit, and coefficient of variation (CV). Results: Across all subjects, the mean difference between TRK-3 OMNIA and GAT IOP measurements was -0.2 mmHg. TRK-3 OMNIA overestimated IOP in the low IOP group (mean difference: 2.1 mmHg, LoA: -1.2 to 5.4 mmHg) and underestimated in the high IOP group (mean difference: -2.4 mmHg, LoA: -5.9 to 1.1 mmHg), while agreement was highest in the intermediate IOP group (-0.2 mmHg, LoA: -2.9 to 2.5 mmHg). Despite the systematic trend, equivalence testing confirmed statistical equivalence across all groups, with 90% confidence intervals (CI) of 1.7 to 2.5 mmHg (low IOP group), -0.6 to 0.2 mmHg (intermediate IOP group), and -2.9 to -2.0 mmHg (high IOP group). Linear regression analysis found a strong correlation (r = 0.92) between TRK-3 and GAT. The TRK-3 OMNIA demonstrated good repeatability, with an ICC of 0.94, a repeatability limit of 3.12 mmHg, and a CV of 5.65%. The repeatability limits were 2.22 mmHg, 2.60 mmHg, and 4.19 mmHg in the low, intermediate, and high IOP groups, respectively. Conclusions: TRK-3 OMNIA and GAT measurements showed strong agreement, statistical equivalence, and a high correlation, supporting their clinical interchangeability. TRK-3 also demonstrated high repeatability. These findings indicate that this automated non-contact tonometer provides reliable and repeatable IOP measurements, supporting its integration into routine clinical workflows.