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临床试验/NCT03292419
NCT03292419已完成不适用

A Prospective Evaluation of Topography-guided LASIK Surgery

Stanford University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Epithelial thickness maps

研究概览

简要总结

The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism

详细描述

The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism. The investigators will be monitoring changes in anterior segment optical coherence tomography epithelial thickness maps. The investigators will compare preoperative maps to postoperative maps at one, three, six and twelve months. In addition, the investigators will measure changes in epithelial maps from postoperative month through twelve months to help understand what is happening to the corneal epithelium to try to explain why UDVA and CDVA improves over time

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

N0ne

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Subjects age 18 and older with healthy eyes. Nearsightedness between -0.50 diopters and -8.00 diopters.
  • •Subjects with up to 3.00 diopters of astigmatism.
  • •Subjects with a spherical equivalent of up to -9.00 diopters.

排除标准

  • •Subjects under the age of
  • •Subjects with excessively thin corneas.
  • •Subjects with topographic evidence of keratoconus.
  • •Subjects with ectatic eye disorders.
  • •Subjects with autoimmune diseases.
  • •Subjects who are pregnant or nursing.
  • •Subjects with more than 3.00 diopters of astigmatism

研究组 & 干预措施

Topography guided LASI

Other

干预措施: Topography-guided LASIK (Procedure)

结局指标

主要结局

Epithelial thickness maps

时间窗: 12 months

Changes in anterior segment optical coherence tomography epithelial thickness maps.

次要结局

  • Contrast visual acuity(12 months)
  • Change in refraction over time(12 months)
  • Predictability(12 months)
  • Changes in corrected visual acuity(12 months)
  • Uncorrected distance visual acuity(12 months)
  • Quality of Vision(12 months)
  • Residual astigmatism levels after surgery(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edward E. Manche

Professor of Ophthalmology

Stanford University

研究点 (1)

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