Purpose This study aimed to evaluate the specificity of commonly used cluster criteria for defining the presence of glaucomatous visual field abnormalities and the impact of variations in the criterion used.
Methods This is an observational study including 607 eyes from 384 healthy participants, and 501 eyes of 345 participants with glaucoma, with at least two reliable 24–2 visual field tests. An abnormal visual field cluster was defined as the presence of ≥3 contiguous abnormal locations. Variations in this definition were evaluated and included (1) whether abnormalities were based on total deviation and/or pattern deviation values; (2) probability cut-off for defining an abnormal location; and (3) whether abnormalities were required to be repeatable (within the same hemifield or at the same locations) or not. These definitions were also compared against pattern standard deviation (PSD) values.
Results False-positive rates of various cluster criteria ranged between 9% and 46% depending on the specific definitions used. Only definitions that required abnormalities to be repeatable at the same location achieved a false-positive rate of ≤6%. The various cluster criteria generally performed similarly or worse at detecting glaucoma eyes compared with the PSD values.
Conclusions Commonly used visual field cluster criteria have high false-positive rates that vary widely depending on the definition used. These findings highlight the need to carefully consider the criteria used when designing and interpreting glaucoma clinical studies.
Trial registration number NCT00221923.
- diagnostic tests/investigation
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Contributors All the authors have contributed to the planning, conduct and reporting of the work described in the article.
Funding Supported in part by National Institutes of Health/National Eye Institute Grants EY021818 (FAM) EY011008, EY14267, EY027510 and EY019869 (LMZ), and Core Grant P30EY022589; EY026574 (LMZ and CAG); grants for participants’ glaucoma medications from Alcon, Allergan, Pfizer, Merck, and Santen; a National Health & Medical Research Council Early Career Fellowship (#1104985, ZW). The sponsors or funding organisations had no role in the design or conduct of this research.
Competing interests ZW: None. FAM: Financial support—Alcon Laboratories (Fort Worth, Texas, USA), Bausch & Lomb (Garden City, New York, USA), Carl Zeiss Meditec (Jena, Germany), Heidelberg Engineering (Heidelberg, Germany), Merck (White House Station, New Jersey, USA), Allergan (Irvine, California, USA), Topcon (Livermore, California, USA), Reichert (Dewey, New York, USA), National Eye Institute (Bethesda, Maryland, USA); Research support—Alcon Laboratories (Fort Worth, Texas, USA), Allergan (Irvine, California, USA), Carl Zeiss Meditec (Jena, Germany), Reichert (Dewey, New York, USA); Consultant—Allergan (Irvine, California, USA), Carl-Zeiss Meditec (Jena, Germany), Novartis (Basel, Switzerland). RNW: Financial support—Heidelberg Engineering, Carl Zeiss Meditec, Genentech, Konan, Optovue, Topcon, Optos, Centervue; Consultant—Aerie Pharmaceuticals, Alcon, Allergan, Bausch & Lomb, Eyenovia, Novartis, Sensimed, Unity, Valeant. CAG: Financial support—National Eye Institute, EyeSight Foundation of Alabama, Research to Prevent Blindness, Heidelberg Engineering, GmbH, SOLX. LMZ: Financial Support—National Eye Institute, Carl Zeiss Meditec, Heidelberg Engineering GmbH, Optovue, Topcon Medical Systems; Consultant—Merck; Recipient—Optovue, Topcon Medical Systems.
Patient consent for publication Not required.
Ethics approval University of California, San Diego (UCSD) Institutional Review Board (#140276).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on request.
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