Tony Realini1, Linda M Zangwill, John G Flanagan, David Garway-Heath, Vincent M Patella, Chris A Johnson, Paul H Artes, Ian B Gaddie, Murray Fingeret. 1. *Department of Ophthalmology, West Virginia University Eye Institute, Morgantown, WV †Department of Ophthalmology, Hamilton Glaucoma Center, University of California, San Diego, La Jolla ∥Carl Zeiss Meditec Inc., Dublin, CA ‡School of Optometry, University of California, Berkeley. Berkeley, CA #Department of Ophthalmology and Vision Sciences, Dalhousie University, Halifax, NS, Canada §National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK ¶Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, IA **Private Practice, Louisville, KY ††VA New York Harbor Health Care System, Brooklyn ‡‡SUNY College of Optometry, New York, NY.
Abstract
PURPOSE: To describe the process by which imaging devices undergo reference database development and regulatory clearance. The limitations and potential improvements of reference (normative) data sets for ophthalmic imaging devices will be discussed. METHOD: A symposium was held in July 2013 in which a series of speakers discussed issues related to the development of reference databases for imaging devices. RESULTS: Automated imaging has become widely accepted and used in glaucoma management. The ability of such instruments to discriminate healthy from glaucomatous optic nerves, and to detect glaucomatous progression over time is limited by the quality of reference databases associated with the available commercial devices. In the absence of standardized rules governing the development of reference databases, each manufacturer's database differs in size, eligibility criteria, and ethnic make-up, among other key features. CONCLUSIONS: The process for development of imaging reference databases may be improved by standardizing eligibility requirements and data collection protocols. Such standardization may also improve the degree to which results may be compared between commercial instruments.
PURPOSE: To describe the process by which imaging devices undergo reference database development and regulatory clearance. The limitations and potential improvements of reference (normative) data sets for ophthalmic imaging devices will be discussed. METHOD: A symposium was held in July 2013 in which a series of speakers discussed issues related to the development of reference databases for imaging devices. RESULTS: Automated imaging has become widely accepted and used in glaucoma management. The ability of such instruments to discriminate healthy from glaucomatous optic nerves, and to detect glaucomatous progression over time is limited by the quality of reference databases associated with the available commercial devices. In the absence of standardized rules governing the development of reference databases, each manufacturer's database differs in size, eligibility criteria, and ethnic make-up, among other key features. CONCLUSIONS: The process for development of imaging reference databases may be improved by standardizing eligibility requirements and data collection protocols. Such standardization may also improve the degree to which results may be compared between commercial instruments.
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