1. Intraocular Pressure Measurement Accuracy and Repeatability of a Modified Goldmann Prism: Multicenter Randomized Clinical Trial
- Author
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Jason Levine, Ann Z McColgin, Kyle Tetrault, Sean McCafferty, Melissa Muller, and Warren Chue
- Subjects
0301 basic medicine ,Adult ,Male ,medicine.medical_specialty ,Accuracy and precision ,Intraocular pressure ,genetic structures ,Ansi standards ,Statistical difference ,Article ,law.invention ,03 medical and health sciences ,Tonometry, Ocular ,0302 clinical medicine ,Randomized controlled trial ,law ,Ophthalmology ,medicine ,Humans ,Prospective Studies ,Intraocular Pressure ,Analysis of Variance ,business.industry ,Reproducibility of Results ,Repeatability ,Middle Aged ,eye diseases ,Surface replacement ,stomatognathic diseases ,030104 developmental biology ,030221 ophthalmology & optometry ,Female ,Ocular Hypertension ,Prism ,sense organs ,business - Abstract
Purpose To clinically evaluate a modified surface Goldmann applanation tomometer (GAT) prism for intraocular pressure (IOP) accuracy, repeatability, and safety. Design Prospective, open-label, randomized, controlled, multicenter reference device reliability and validity analysis. Methods A GAT and a modified surface GAT prism measured IOP on 173 unique eyes. The study design and analysis complied with FDA 510(k) and ANSIZ80.10-2014 guidelines. All eyes were randomized to IOP measurement by 1 of 5 standard prisms or 5 modified prisms, each from a different manufacturing lot. Pressures were measured by 6 investigators, 2 times with each prism, for a total of 1384 IOP measurements. Analysis included Bland-Altman difference accuracy, intraoperator and interoperator IOP measurement, and manufactured lot repeatability. Results Bland-Altman indicated no IOP measurements pairs outside the ±5 mm Hg guidelines. Operator and manufactured lot repeatability F tests and 1-way ANOVAs indicated no statistical difference between the standard and modified prisms (all P > .10). The difference in IOP measurements of the standard and modified prisms correlated well to Dresdner central corneal thickness (CCT) correction (P = .01). Conclusion A modified surface replacement prism is statistically equivalent to a flat-surfaced prism. The modified surface prism indicated statistically significant correction for CCT requiring further testing outside the ANSI standard limits (0.500 mm
- Published
- 2018