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

Area of Science:

• Ophthalmology
• Optometry
• Biomedical Engineering

Background:

• Accurate intraocular pressure (IOP) measurement is crucial for diagnosing and managing glaucoma.
• Goldmann applanation tonometry (GAT) is the gold standard, but non-contact tonometers (NCTs) offer convenience.
• Evaluating the clinical interchangeability and repeatability of new NCT devices is essential.

Purpose of the Study:

• To assess the clinical interchangeability of intraocular pressure (IOP) measurements between the TRK-3 OMNIA NCT and Goldmann applanation tonometry (GAT).
• To evaluate the repeatability of IOP measurements obtained with the TRK-3 OMNIA.
• To determine the correlation and agreement across different IOP ranges.

Main Methods:

• Prospective, multicenter study involving 120 subjects stratified into low, intermediate, and high IOP groups based on GAT.
• IOP measurements were taken using both TRK-3 OMNIA and GAT following a standardized protocol.
• Statistical analysis included Bland-Altman analysis, equivalence testing (TOST), and linear regression; repeatability assessed via ICC, repeatability limit, and CV.

Main Results:

• Mean difference between TRK-3 OMNIA and GAT was -0.2 mmHg, with strong correlation (r=0.92).
• Statistical equivalence confirmed across all IOP groups, despite slight overestimation in low and underestimation in high IOP ranges.
• TRK-3 OMNIA demonstrated good repeatability (ICC=0.94, CV=5.65%), with repeatability limits varying by IOP group.

Conclusions:

• The TRK-3 OMNIA tonometer shows strong agreement, statistical equivalence, and high correlation with GAT, supporting clinical interchangeability.
• The device exhibits high repeatability, indicating reliability for IOP measurements.
• The TRK-3 OMNIA is a suitable tool for routine clinical workflows, providing dependable IOP assessments.