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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 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 < CCT < 0.600 mm) to examine its full potential.

SUBMITTER: McCafferty S

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

REPOSITORIES: biostudies-literature

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

McCafferty Sean S Tetrault Kyle K McColgin Ann A Chue Warren W Levine Jason J Muller Melissa M

American journal of ophthalmology 20180907

<h4>Purpose</h4>To clinically evaluate a modified surface Goldmann applanation tomometer (GAT) prism for intraocular pressure (IOP) accuracy, repeatability, and safety.<h4>Design</h4>Prospective, open-label, randomized, controlled, multicenter reference device reliability and validity analysis.<h4>Methods</h4>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 IO ...[more]

PMID: 30195894

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Project description:PurposeCompare intraocular pressure (IOP) measured by a standard Goldmann applanation tonometer prism (IOPg) and a modified correcting applanation tonometer surface Goldmann prism (IOPc) before and after laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK).MethodsGoldmann tonometry was analyzed in a retrospective, cross-sectional study, using both GAT and modified-GAT prisms pre-operatively and at the 3 month post-operative appointment on 120 eyes (64 patients) who received LASIK (n = 58) or PRK (n = 62). Demographics, central corneal thickness (CCT), manifest refraction and corneal curvature (CC) data was collected at each visit as well as surgical parameters, including maximum ablation depth.ResultsMean paired IOP following LASIK decreased by - 3.28 ± 3.2 mmHg measured by IOPg and - 1.93 ± 3.3 mmHg by IOPc (p ≤ 0.0001). Mean paired IOP following PRK reduced by - 1.92 ± 3.6 mmHg measured by IOPg and - 1.06 ± 3.6 mmHg by IOPc (p ≤ 0.0001). Increased LASIK ablation depth and post-procedural change in CCT trended toward a statistically significant reduction in IOPg (p = 0.07,p = 0.12), but not IOPc (p = 0.18,p = 0.32). PRK ablation depth was not associated with a reduction in IOPg or IOPc.DiscussionThe modified Goldmann (IOPc) prism measured less of an IOP reduction following LASIK and PRK compared to the standard (IOPg) prism, and the IOP reduction with both prisms was associated with the degree of myopic correction.What is already known and the residual queryCorneal refractive surgery generally demonstrates significant postoperative Goldmann IOP reductions. Presumably, this is due to corneal biomechanical changes for which a newer method of Goldmann IOP measurement may be able to compensate.What this study addsA modified, corneal conforming Goldmann prism demonstrates significantly less IOP reduction following myopic LASIK and PRK compared to the standard flat Goldmann prism.How this study might affect research, practice or policyA newer, modified Goldmann prism may help detect glaucoma and OHT at an earlier stage in patients which have undergone LASIK or PRK. The findings corroborate predicted corneal biomechanical changes following the most common corneal refractive procedures.

Project description:ImportanceThe ability of patients to measure their own intraocular pressure (IOP) would allow more frequent measurements and better appreciation of peak IOP and IOP fluctuation.ObjectiveTo examine whether patients with glaucoma can perform self-tonometry using a rebound tonometer and examine patient acceptability.Design, setting, and participantsAn observational study in which IOP was assessed using Goldmann applanation tonometry and a rebound tonometer. Consecutive patients were provided with a patient information sheet and those consenting to take part in the study received standardized self-tonometry training and were then instructed to measure their own IOP under observation. This study was conducted at a glaucoma clinic at a university hospital from March 1, 2016, to December 30, 2016, and included both eyes of 100 patients with glaucoma or ocular hypertension.Main outcomes and measuresThe percentage of patients who could successfully perform self-tonometry. Complete success was defined by a good technique and an IOP reading within 5 mm Hg of that obtained by a clinician using the same device. A 3-item questionnaire was used to examine perceptions of self-tonometry among patients.ResultsAmong the 100 patients, the mean (SD) age was 67.5 (10.9) years (53% female). A total 73 of 100 patients (73%) met the complete success criteria. An additional 6 patients could use the device but had IOP readings greater than 5 mm Hg different from those obtained by the clinician. On average, IOP by the rebound tonometer was 2.66 mm Hg lower than Goldmann applanation tonometry (95% limits of agreement, -3.48 to 8.80 mm Hg). The IOPs with the rebound tonometer were similar whether obtained by self-tonometry or investigator, with excellent reproducibility with an intraclass correlation coefficient of 0.903 (95% CI, 0.867-0.928). A total of 56 of 79 successful or partially successful patients (71%) felt self-tonometry was easy, with 73 of 79 (92%) reporting self-tonometry to be comfortable, and a similar number happy to perform self-tonometry in the future.Conclusions and relevanceMost patients could perform self-tonometry and the method was acceptable to patients. Self-tonometry has the potential to improve patient engagement, while also providing a more complete picture of IOP changes over time.

Dataset Information

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

Publications

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

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