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临床试验/NCT00778570
NCT00778570Unknown不适用

A Combined Retrospective and Prospective Chart Review Analysis of Visual Outcomes Following Excimer Laser Vision Correction

Ottawa Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2007年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
4,000
试验地点
1
主要终点
Visual Acuity

研究概览

简要总结

The purpose of this combined retrospective and prospective chart review analysis is to investigate the safety, efficacy, and predictability obtained via Laser-Assisted In Situ Keratomileusis (LASIK) and Advanced Surface Ablation (ASA) over a wide range of refractive errors

The working hypothesis is that there will be no difference in clinical outcomes between patients treated with LASIK or ASA.

详细描述

Excimer laser vision correction (LVC) is a widely used procedure to correct nearsightedness, farsightedness, and astigmatism by reshaping the surface of the eye (cornea). Laser-Assisted In Situ Keratomileusis (LASIK) and Advanced Surface Ablation (ASA) and are techniques currently used to prepare the cornea for Excimer LVC.

This review is intended to study whether LASIK is equal in visual outcome (null hypothesis), more effective (alternate hypothesis 1) or less effective (alternate hypothesis 2) than ASA in clinical outcome up to one year.

研究设计

研究类型
Observational

入排标准

性别
All
接受健康志愿者

入选标准

  • Eyes that were treated for LASIK or ASA Excimer laser vision correction before December 1st 2006 and newly recruited eyes that qualify for LASIK or ASA Excimer laser vision correction may be enrolled in this study.

排除标准

  • There are no exclusion criteria; all patients that went forward with Excimer laser vision correction may be included.

结局指标

主要结局

Visual Acuity

时间窗: 1 day, 1W, 1M, 3M, 6M, 9M, 12M

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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