Repeatability, reproducibility, agreement, and safety of Tono-Pen tip cover for intraocular measurement using latex and polyethylene wrap

Abstract

To evaluate repeatability, reproducibility, and agreement of intraocular pressure measurement with Tono-Pen using Ocufilm and polyethylene wrap tip cover in human eyes. Methods This is a cross-sectional, experimental study. A gas-sterilized, polyethylene wrap was used as an alternative for Tono-Pen tip cover. For the right eye, 4 measurements using polyethylene wrap tip cover were done by two examiners (A and B) in random order to assess intraobserver repeatability and inter-observer reproducibility. For the left eye, 4 measurements were done by examiner A using both polyethylene wrap tip cover and Ocufilm in random order to assess intra-observer repeatability and agreement. Bland-Altman plot and intraclass correlation coefficient (ICC) were used in all analyses. Cost minimization analysis was evaluated. Results For examiner A, the repeatability of polyethylene wrap tip cover was-0.34, 95% limits of agreement (LOA) were-3.04 to 2.36, and ICC was 0.93 in the right eyes. As for the left eyes, the repeatability of polyethylene wrap tip cover was-0.33, 95% LOA were-3.01 to 2.36, and ICC was 0.93. For examiner B, the repeatability of polyethylene wrap tip cover was-0.02, 95% LOA were-2.88 to 2.83, and ICC was 0.92. The inter-observer reproducibility of polyethylene wrap tip cover was 0.36, 95% LOA were-3.34 to 4.07, and ICC was 0.90. The repeatability of Ocufilm was-0.42, 95% LOA were-2.75 to 1.91, and ICC was 0.95. The agreement of polyethylene wrap tip cover and Ocufilm was-0.71, 95% LOA were-5.18 to 3.76, and ICC was 0.83. There were no allergic reactions or serious complications. From the

Repeatability, reproducibility, agreement, and safety of tono-pen tip cover for intraocular measurement using latex and polyethylene wrap

“…In addition, the ICC showed moderate to good agreement. Similar results were found in our previous studies on eye model (MD = 0.29, 95% LOA = -5.68 to 6.26) 18 and canine eye (MD = 0.13, 95% LOA = -3.92 to 4.18). 19 Thus, PE and OF could be used as TP tip cover interchangeably.…”

“…These results were similar to our previous studies that used PE in an eye model (intra-rater repeatability = -0.25 mmHg, 95% LOA = -4.55 to 4.05 mmHg) 18 and canine eyes (intra-rater repeatability = 0.27 mmHg, 95% LOA = -2.74 to 3.27 mmHg). 19 The inter-rater reproducibility of PE (0.36 mmHg) and LOA (-3.34 to 4.07 mmHg) was acceptable (Table 4) and comparable to our previous study in canine eyes (interrater reproducibility = -0.39 mmHg, 95% LOA = -4.79 to 4.01 mmHg). 19 PE and OF are different in many aspects, including materials and thickness.…”

“…19 The inter-rater reproducibility of PE (0.36 mmHg) and LOA (-3.34 to 4.07 mmHg) was acceptable (Table 4) and comparable to our previous study in canine eyes (interrater reproducibility = -0.39 mmHg, 95% LOA = -4.79 to 4.01 mmHg). 19 PE and OF are different in many aspects, including materials and thickness. The thickness of PE is 10 microns.…”

“…16,17 Our previous studies on an eye model and canine eyes showed good repeatability and agreement between a custom-made polyethylene wrap tip cover (PE) and OF without causing any ocular surface complications. 18,19 The purpose of this study is to evaluate repeatability, reproducibility and agreement of the IOP measured by TP using OF and PE in human eyes, their safety and cost comparison between both tip covers.…”