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临床试验/NCT02763124
NCT02763124已完成不适用

Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions

Gainesville Eye Associates2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年5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
发起方
入组人数
18
试验地点
2
主要终点
Uncorrected Monocular Distance Visual Acuity

研究概览

简要总结

To assess the effectiveness of the Verion-LenSx guided arcuate incision technique to reduce astigmatism in a pseudophakic population.

详细描述

The purpose of this study is to evaluate the effectiveness of corneal arcuate incisions when they are performed with a femtosecond laser system on subjects who have had previous cataract surgery. The procedure to be used would not be different from that employed during cataract surgery, except that the only corneal incisions made would be the partial-depth arcuate incisions at the laser.

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40 or older
  • Willing and able to provide informed consent for participation in the study.

排除标准

  • 未提供

研究组 & 干预措施

Verion-LenSx

Experimental

The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions.

干预措施: Verion-LenSx (Procedure)

结局指标

主要结局

Uncorrected Monocular Distance Visual Acuity

时间窗: 60 days (+/- 10 days) after laser treatment

Uncorrected monocular distance visual acuity, measured on a logMAR scale, (logarithm of the Minimum Angle of Resolution) which is a measure of visual acuity in which the smaller values indicate better visual acuity.

次要结局

  • Change in Corneal Astigmatism(60 days (+/- 10 days) after laser treatment)
  • Change in Refractive Cylinder(60 days (+/- 10 days) after laser treatment)
  • Spectacle Independence at Distance(60 days (+/- 10 days) after laser treatment)

研究者

发起方
Gainesville Eye Associates
申办方类型
Other
责任方
Principal Investigator
主要研究者

Clayton Blehm, MD

PI

Gainesville Eye Associates

研究点 (2)

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