title: Standardized analyses of correction of astigmatism by laser systems that reshape the cornea.
abstract: OBJECTIVE
  To develop a minimum set of analyses and a format for presentation of outcomes of astigmatism correction by laser systems that reshape the cornea.
  
  
  METHODS
  An Astigmatism Project group was created under the auspices of the American National Standards Institute (ANSI) Z80.11 Working Group on Laser Systems for Corneal Reshaping. The Astigmatism Project Group was made up of experts in astigmatism analyses from academia, government, and industry. An extensive literature review was conducted to identify all currently available methodologies for the evaluation of astigmatic outcomes. Project Group members discussed the utility of each method and its specific parameters for evaluating the effectiveness of astigmatism-correcting devices. They gave consideration to unique terminology and analyses required for evaluation of correction of astigmatism by laser systems that reshape the comea.
  
  
  RESULTS
  The Project Group defined a comprehensive list of analysis variables needed for the evaluation of astigmatism-correcting devices and generated a mathematical definition for each term. They developed a minimum set of analyses needed for evaluation of astigmatism treatments by laser systems that reshape the cornea. They established methods for calculating the refractive error analysis variables and constructed recommended table and graph formats for data presentation.
  
  
  CONCLUSIONS
  This article contains the recommendations of the Astigmatism Project Group of the American National Standards Institute. We propose it as a standard reference for astigmatic refractive error analyses for the evaluation of safety and effectiveness of laser systems that reshape the cornea.
authors.affiliation: Division of Ophthalmic and Ear, Nose and Throat Devices, Food and Drug Administration, Rockville, MD 20850, USA. MALVINA.EYDELMAN@FDA.HHS.GOV
authors.forename: Malvina B
authors.initials: MB
authors.lastname: Eydelman
authors.forename: Bruce
authors.initials: B
authors.lastname: Drum
authors.forename: Jack
authors.initials: J
authors.lastname: Holladay
authors.forename: Gene
authors.initials: G
authors.lastname: Hilmantel
authors.forename: Guy
authors.initials: G
authors.lastname: Kezirian
authors.forename: Daniel
authors.initials: D
authors.lastname: Durrie
authors.forename: R Doyle
authors.initials: RD
authors.lastname: Stulting
authors.forename: Donald
authors.initials: D
authors.lastname: Sanders
authors.forename: Bonita
authors.initials: B
authors.lastname: Wong
mesh_terms: D001251:Astigmatism / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D003315:Cornea / Q000473:pathology* / Q000601:surgery; D006801:Humans; D053685:Laser Therapy / Q000295:instrumentation / Q000592:standards; D012029:Refraction, Ocular