Standardized analyses of correction of astigmatism by laser systems that reshape the cornea.
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.
Eydelman
Malvina B
MB
Division of Ophthalmic and Ear, Nose and Throat Devices, Food and Drug Administration, Rockville, MD 20850, USA. MALVINA.EYDELMAN@FDA.HHS.GOV
Drum
Bruce
B
Holladay
Jack
J
Hilmantel
Gene
G
Kezirian
Guy
G
Durrie
Daniel
D
Stulting
R Doyle
RD
Sanders
Donald
D
Wong
Bonita
B
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