Intraocular Pressure Measurement Accuracy and Repeatability of a Modified Goldmann Prism: Multicenter Randomized Clinical Trial.

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 me

SUBMITTER: McCafferty S 

PROVIDER: S-EPMC6366945 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature