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通过重塑角膜的激光系统对散光进行矫正的标准化分析。

Standardized analyses of correction of astigmatism by laser systems that reshape the cornea.

作者信息

Eydelman Malvina B, Drum Bruce, Holladay Jack, Hilmantel Gene, Kezirian Guy, Durrie Daniel, Stulting R Doyle, Sanders Donald, Wong Bonita

机构信息

Division of Ophthalmic and Ear, Nose and Throat Devices, Food and Drug Administration, Rockville, MD 20850, USA.

出版信息

J Refract Surg. 2006 Jan-Feb;22(1):81-95. doi: 10.3928/1081-597X-20060101-16.

Abstract

PURPOSE

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.

摘要

目的

制定一套最少的分析方法以及一种用于呈现通过重塑角膜的激光系统进行散光矫正结果的格式。

方法

在美国国家标准学会(ANSI)Z80.11角膜重塑激光系统工作组的支持下成立了一个散光项目组。该散光项目组由来自学术界、政府和行业的散光分析专家组成。进行了广泛的文献综述,以确定所有目前可用于评估散光矫正结果的方法。项目组成员讨论了每种方法的实用性及其用于评估散光矫正设备有效性的具体参数。他们考虑了评估通过重塑角膜的激光系统进行散光矫正所需的独特术语和分析方法。

结果

项目组定义了评估散光矫正设备所需的分析变量的综合列表,并为每个术语给出了数学定义。他们制定了一套最少的分析方法,用于评估通过重塑角膜的激光系统进行的散光治疗。他们建立了计算屈光不正分析变量的方法,并构建了推荐的数据呈现表格和图表格式。

结论

本文包含美国国家标准学会散光项目组的建议。我们将其作为散光屈光不正分析的标准参考文献,用于评估重塑角膜的激光系统的安全性和有效性。

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