Dataset Information

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

ABSTRACT: PURPOSE: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 intra-observer 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 cost minimization analysis, the local cost for polyethylene tip cover was approximately 8 times lower compared to Ocufilm. CONCLUSIONS:Tono-pen with Ocufilm and polyethylene wrap tip cover were used to measure the intraocular pressure. The polyethylene wrap tip cover demonstrated acceptable repeatability, reproducibility, and agreement with Ocufilm in normotensive eyes, and had a good safety profile.

SUBMITTER: Suvannachart P

PROVIDER: S-EPMC7521710 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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

Suvannachart Pukkapol P Asawaphureekorn Somkiat S Chansangpetch Sunee S Inobhas Abhibol A Pongpirul Krit K

PloS one 20200928 9

<h4>Purpose</h4>To evaluate repeatability, reproducibility, and agreement of intraocular pressure measurement with Tono-Pen using Ocufilm and polyethylene wrap tip cover in human eyes.<h4>Methods</h4>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 intra-observer repeatability and in ...[more]

PMID: 32986771

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Project description:PurposeTo evaluate the repeatability and reproducibility of corneal power measurements obtained by Topcon KR-1W and iTrace, and assess the agreement with measurements obtained by Allegro Topolyzer and IOLMaster.MethodsThe right eyes of 100 normal subjects were prospectively scanned 3 times using all the 4 devices. Another observer performed additional 3 consecutive scans using the Topcon KR-1W and iTrace in the same session. About one week later, the first observer repeated the measurements using the Topcon KR-1W and iTrace. The steep keratometry (Ks), flat keratometry (Kf), mean keratometry (Km), J0 and J45 were analyzed. Repeatability and reproducibility of measurements were evaluated by the within-subject standard deviation (Sw), coefficient of variation (CoV), test-retest repeatability (2.77Sw), and intraclass correlation coefficient (ICC). Agreements between devices were assessed using Bland-Altman analysis and 95% limits of agreement (LoA).ResultsIntraobserver repeatability and interobserver and intersession reproducibility of the Ks, Kf and Km showed a CoV of no more than 0.5%, a 2.77Sw of 0.70 D or less, and an ICC of no less than 0.99. However, J0 and J45 showed poor intraobserver repeatability and interobserver and intersession reproducibility (all ICCs not greater than 0.446). Statistically significant differences existed between Topcon KR-1W and IOLMaster, Topcon KR-1W and iTrace, Topcon KR-1W and Topolyzer, iTrace and Topolyzer, iTrace and IOLMaster for Ks, Kf and Km measurements (all P < 0.05). The mean differences between Topcon KR-1W, iTrace, and the other 2 devices were small. The 95% LoA were approximately 1.0 D to 1.5 D for all measurements.ConclusionsThe Ks, Kf and Km obtained by Topcon KR-1W and iTrace showed excellent intraobserver repeatability and interobserver and intersession reproducibility in normal eyes. The agreement between Topcon KR-1W and Topolyzer, Topcon KR-1W and IOLMaster, iTrace and Topolyzer, iTrace and IOLMaster, Topcon KR-1W and iTrace were not so good, they should not be interchangeable in clinical application. Given that the intraobserver repeatability and interobserver and intersession reproducibility of corneal astigmatism measurements obtained by Topcon KR-1W and iTrace were poor, it should be cautious that Topcon KR-1W and iTrace were applied for the preparation of toric lens implantation.

Dataset Information

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

Publications

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

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