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临床试验/NCT04903301
NCT04903301已完成不适用

Patient Satisfaction With Contoura Vision Topography-Guided LASIK

Rush Eye Associates1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年5月21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
50
试验地点
1
主要终点
Global Vision Satisfaction Index

研究概览

简要总结

To evaluate patient reported outcomes associated with quality of vision before and after treatment with Contoura Vision Topography-Guided LASIK.

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

入排标准

年龄范围
21 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Eligibility criteria: The study enrollment will include all willing patients with: pre-operative BCVA 20/20 for each eye individually, myopic refractive error up to -8.00 diopters, refractive astigmatism that ranges from 0 to 3 diopters, maximum spherical equivalent of -9.00 diopters, the designated age requirements, and only patients that have signed the informed consent document.

排除标准

  • •Patients are excluded that are not willing to participate in a research trial, are unable to cooperate well enough to safely perform the procedure, fail to meet inclusion criteria, have ocular disease (including but not limited to keratoconus, macular degeneration, glaucoma, corneal dystrophy, dry eye syndrome and corneal scarring), and patients that have had previous ocular surgery. Any patients with known allergies to the post-operative medications or preservatives in the medications will also be excluded.

研究组 & 干预措施

Study Group

Experimental

Contoura Vision LASIK using Phorcides Analytic Software

干预措施: Contoura Vision LASIK (Procedure)

结局指标

主要结局

Global Vision Satisfaction Index

时间窗: 26 weeks

Analog Score from Adapted from PROWL Survey

次要结局

  • Vision(26 weeks)
  • Higher Order Corneal Aberrations(26 weeks)
  • Objective Scatter Index(26 weeks)

研究者

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

Sloan W. Rush, MD

Principal Investigator

Rush Eye Associates

研究点 (1)

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