Validity and Repeatability of Goldmann Applanation Tonometry When Used in Conjuction With a Prototype Sterile Barrier System

Abstract

Abstract: : Purpose:To determine the differences between Goldmann applanation tonometry results with and without a prototype sterile barrier system. Methods:The prototype barrier system consists of a barrier film that is coated with an adhesive hydrogel. Protective liners maintain the adhesive layer and barrier film sterility until the device is used. 50 subjects consisting of two consecutive series of 25 subjects from two clinical sites. Intraocular pressure (IOP) was measured by slit–lamp mounted Goldmann applanation tonometry, both with and without the sterile barrier. The order of measurement was randomized across the samples. Two IOP readings were taken for each condition. Results:IOP with the barrier was 16.76 ±2.19 mmHg and without the barrier was 16.38 ±2.06 mmHg. The Mean of Differences (MoD) was 0.38 ±0.62 mmHg, with a Coefficient of Repeatability (CoR) (95% CLs) of 1.21 mmHg. The mean of the two measurements taken with the barrier were 17.00 ±2.16 and 16.64 ±2.40 mmHg, with an MoD of 0.36 ±1.08, and a CoR of 2.11mmHg. The mean of the two measurements taken without the barrier were 16.56 ±2.18 and 16.20 ±2.06 mmHg, with an MoD of 0.36 ±1.04, and a CoR of 2.03mmHg. No adverse responses reported. Conclusions:The IOP was 0.38mmHg greater with the barrier than without. The difference was similar to that found between the two IOP measurements, both with and without the prototype sterile barrier.

Keywords: intraocular pressure