Evidence map›Paper›PMID 30195894›Full record

Trial reportAmerican journal of ophthalmology2018

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

Sean McCafferty, Kyle Tetrault, Ann McColgin, Warren Chue, Jason Levine, Melissa Muller

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of ophthalmology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Sean McCaffertyArizona Eye Consultants, Intuor Technologies, Tucson, Arizona, USA. Electronic address: SJMccafferty66@hotmail.com.
Kyle TetraultDenver Eye Surgeons, Lakewood, Colorado, USA.
Ann McColginCornea Associates, Tucson, Arizona, USA.
Warren ChueArizona Eye Consultants, Tucson, Arizona, USA.
Jason LevineArizona Eye Consultants, Tucson, Arizona, USA.
Melissa MullerArizona Eye Consultants, Tucson, Arizona, USA.

Funding

Goldmann Contact Tonometry with Optimized Error CorrectionR43EY026821 · NEI · INTUOR TECHNOLOGIES, LLC · PI MCCAFFERTY, SEAN J · 2016 to 2016
$175k
NEI NIH HHS R43 EY026821
6 · The paper itself

Abstract

purposeTo clinically evaluate a modified surface Goldmann applanation tomometer (GAT) prism for intraocular pressure (IOP) accuracy, repeatability, and safety.

designProspective, open-label, randomized, controlled, multicenter reference device reliability and validity analysis.

methodsA 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.

resultsBland-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).

conclusionA 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.

Indexed as

AdultAnalysis of VarianceFemaleHumansIntraocular PressureMaleMiddle AgedOcular HypertensionProspective StudiesReproducibility of ResultsTonometry, Ocular

Identifiers

PMID30195894
PMCPMC6366945

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.