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临床试验/NCT01138189
NCT01138189已完成不适用

A Prospective Eye to Eye Comparison of LASIK Using Wavefront-guided Treatment Versus Wavefront-optimized Treatment

Edward E. Manche1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2010年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Refractive predictability

研究概览

简要总结

The purpose of the study is to compare the results of LASIK surgery when using wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser treatment in patients with nearsightedness with and without astigmatism

详细描述

This is a research study comparing the outcomes of LASIK surgery for nearsightedness when using the two different excimer laser technologies. Patients will have both eyes treated with the Alcon WaveLight Allegretto excimer laser. You will be one of 150 sighted patients at Stanford to undergo treatment in this clinical research trial. This will be a prospective, randomized, research study in which up to 300 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) using one laser technology in the first eye and the second laser technology in the fellow eye for the correction of myopia (nearsightedness) with or without astigmatism will be enrolled. The choice of which eye receives the wavefront guided technology and which eye receives the wavefront-optimized technology will be randomized prior to enrollment. Randomization will be done according to a randomization schedule. You will know which eye is being treated with which each technology. The randomization will determine only whether your right or left eye is treated with the wavefront guided technology. The other eye will be treated with wavefront-optimized laser technology. You have a fifty percent chance of having your left eye treated with custom wavefront guided technology as your right eye. Subjects will undergo bilateral (both eyes at once) LASIK treatments using the Alcon WaveLight Allegretto excimer laser. All subjects will be followed for one year after the vision correction procedure. Subjects scheduled to undergo LASIK for the correction of myopia (nearsightedness) with or without astigmatism will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, subjects will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Retreatments (a second operation on the same eye for residual nearsightedness) will not be allowed during the first twelve months of this study. If you elect to undergo a retreatment of your LASIK surgery prior to the 12-month post-operative visit, the retreated eye will be exited from the study as of the retreatment date.

Any significant new finding developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject or subject's representative in a timely manner.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects age 21 and older with healthy eyes.
  • Nearsightedness between -7.50 diopters and -7.00 diopters with or without astigmatism of up to 3.50 diopters.

排除标准

  • Subjects under the age of
  • Patients with excessively thin corneas.
  • Patients with topographic evidence of keratoconus.
  • Patients with autoimmune diseases.
  • Patients who are pregnant or nursing.
  • Patients must have similar levels of nearsightedness in each eye. They can not be more than 3.0 diopter of difference between eyes.
  • Patients must have similar levels of astigmatism in each eye. They can not have more than 4.0 diopters of difference in nearsightedness or astigmatism between their two eyes.

结局指标

主要结局

Refractive predictability

时间窗: 12 months

Uncorrected visual acuity

时间窗: 12 months

Changes in 5 and 25% contrast visual acuity

时间窗: 12 months

Changes in best corrected visual acuity

时间窗: 12 months

次要结局

  • Quality of vision measurement(1 yr)
  • Topographic analysis(1 yr)
  • Changes in higher order aberrations(1 yr)

研究者

发起方
Edward E. Manche
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Edward E. Manche

Stanford University School of Medicine

Stanford University

研究点 (1)

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